FLUENTAL - PACKAGE LEAFLET - LEAFLETS

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Fluental - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Paracetamol, Sobrerol

Fluental 300 mg + 150 mg tablets
Fluental Adults 500 mg + 200 mg suppositories
Fluental Children 250 mg + 100 mg suppositories
Fluental 12.8 mg / ml + 8 mg / ml syrup

Indications Why is Fluental used? What is it for?

Fluental contains the active ingredients paracetamol and sobrerol. This medicine acts against fever and pain and as a thinner of the secretions of the respiratory system.

Fluental is used to treat the symptoms of acute febrile respiratory disorders.

Talk to your doctor if you do not feel better or if you feel worse after 3 days of treatment.

Contraindications When Fluental should not be used

Do not take Fluental

If you are allergic to acetaminophen or sobrerol or any of the other ingredients of this medicine;
If you have a deficiency of glucose-6-phosphate dehydrogenase (an inherited disease which leads to low red blood cell counts);
If you have any of the following diseases:
- decreased number of red blood cells (severe haemolytic anemia);
- decreased liver function (severe hepatocellular insufficiency);
- severe changes in kidney function;
- severe changes in blood cells (blood crasis).

Precautions for use What you need to know before taking Fluental

Talk to your doctor or pharmacist before taking Fluental:

if you have liver or kidney problems (liver or kidney failure), even if not severe;
if you are being treated with medicines that thin the blood (anticoagulants), as in this case Fluental must be administered at a reduced dose;
if you have had sensitivity problems in the past after taking acetylsalicylic acid (such as aspirin) and / or non-steroidal anti-inflammatory drugs (NSAIDs).

Do not use Fluental outside the acute febrile phase and do not take the medicine for more than 3 consecutive days without consulting your doctor.

During treatment with Fluental, before taking any other medicine, check that it does not contain paracetamol, as serious side effects can occur if paracetamol is taken in high doses.

Also, before combining any other medicines, contact your doctor.

Prolonged or high doses of this medicine can cause changes, even severe ones, of the kidneys, blood cells (blood cells) and liver.

Liver damage (hepatotoxicity) can occur with paracetamol even at the prescribed doses, after short-term treatment, even in patients without previous liver disease.

Serious skin reactions: Life-threatening side effects such as Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported with the use of paracetamol. e.g. progressive skin redness associated with blisters or mucosal lesions), discontinue treatment with Fluental immediately and contact the nearest hospital.

For those who play sports: Fluental syrup contains 1.25 vol% ethanol (alcohol). The use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Children: Consult your doctor before giving this medicine to children under 3 years of age.

Interactions Which drugs or foods can modify the effect of Fluental

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Before taking Fluental tell your doctor if you are taking:

cimetidine (used for gastritis and stomach ulcers) or similar medicines. Use Fluental only under strict medical supervision.
alcohol or medicines potentially dangerous for the liver (hepatotoxic), such as rifampicin (an antibiotic) or medicines to treat epilepsy (antiepileptics), for example phenobarbital, phenytoin, carbamazepine or topiramate, because they increase the possibility of side effects from paracetamol ;
medicines that slow down gastric emptying (eg propantheline), as they can reduce the therapeutic effect of paracetamol;
medicines that increase the rate of gastric emptying (eg metoclopramide, domperidone), as they cause an increase in the absorption of paracetamol;
medicines that thin the blood, for example warfarin and similar medicines (vitamin K antagonists), as paracetamol can increase the risk of bleeding; in case of concomitant use, inform your doctor if you notice any bleeding.
non-steroidal anti-inflammatory drugs - NSAIDs (used for pain, fever or inflammation) or opioid medicines (used for pain), as concomitant use may cause an excessive enhancement of the analgesic effect.
flucloxacillin (used for some bacterial infections), due to the risk of acid accumulation in the body (metabolic acidosis) in some patients in special conditions (with risk factors for glutathione depletion).
ethinylestradiol (usually used as a birth control pill), as paracetamol increases its concentration in the blood.
lamotrigine (used for epilepsy and some psychiatric disorders), as paracetamol can reduce its concentration in the blood.

The amount of acetylsalicylic acid (aspirin) and chloramphenicol (an antibiotic) in the blood is increased if these medicines are taken with paracetamol.

Interactions with laboratory tests

Paracetamol can interfere with blood tests for determining uric acid (uric acid) and sugar (blood sugar) levels.

Fluental with alcohol

Avoid using alcoholic beverages, as alcohol increases the risk of liver damage.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Fluental, like any other similar medicine, is not recommended if you intend to become pregnant.

During pregnancy or breastfeeding, use Fluental only if clearly needed and under the direct supervision of your doctor.

Stop taking this medicine if you have fertility problems or are undergoing fertility tests.

Driving and using machines

Due to the possible onset of dizziness, Fluental may impair the ability to drive or use machines.

Fluental syrup contains ethanol (alcohol)

This medicine contains 1.25 vol% ethanol, for example up to 300 mg per dose, equivalent to 7.5 ml of beer, 3.1 ml of wine per dose. It can be harmful to alcoholics.

To be taken into consideration in pregnant or lactating women, children and patients with liver disease or epilepsy.

Fluental syrup contains sucrose

This medicine contains up to 9 g of sucrose per dose. To be taken into consideration in people with diabetes mellitus. If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.

Fluental syrup contains para-hydroxybenzoates (parabens)

This medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (including delayed).

Fluental syrup contains sodium

This medicine may contain up to 2 mmol sodium per dose. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.

Dose, Method and Time of Administration How to use Fluental: Posology

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended doses are:

Adult suppositories: 2 suppositories per day
Suppositories for children: 2 suppositories per day
Tablets: Adults: 2 - 4 tablets per day
Syrup: 4 - 6 teaspoons per day

Do not exceed the maximum total daily dose.

Do not administer for more than 3 consecutive days without consulting your doctor.

Overdose What to do if you have taken too much Fluental

In case of accidental ingestion / intake of an excessive dose of Fluental consult your doctor immediately or go to the nearest hospital.

The disorders of acetaminophen overdose are paleness, nausea, vomiting, loss of appetite (anorexia) and abdominal pain; these complaints generally appear during the first 24 hours after an overdose with acetaminophen.

An overdose of paracetamol can cause destruction of liver cells (hepatic cytolysis) which can lead to insufficient liver function (hepatocellular insufficiency), gastrointestinal bleeding, accumulation of acids in the body (metabolic acidosis), encephalopathy (brain disorders ), coma and death.

An increase in the values of certain liver-related blood tests (hepatic transaminases, lactate dehydrogenase, bilirubin) with a decrease in prothrombin may occur 12 to 48 hours after acute overdose.

Overdose can also lead to inflammation of the pancreas (pancreatitis), reduced kidney function (acute kidney failure) and reduction of all blood cells (pancytopenia).

In severe cases, impaired liver function can occur due to the destruction of liver cells (hepatic insufficiency due to cellular necrosis).

If you forget to take Fluental

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Fluental

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following side effects occur, stop using FLUENTAL and contact your doctor immediately:

very severe rare skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalized exanthematous pustulosis
allergic reactions (hypersensitivity) such as swelling of the skin, mucous membranes, larynx (angioedema), anaphylactic shock
skin irritations (erythema, hives, fixed drug eruption)
decrease in the number of platelets (thrombocytopenia) and white blood cells (neutropenia, leukopenia)
decreased number of white blood cells (agranulocytosis) and red blood cells (haemolytic anemia) in patients with a disease due to a lack of a substance called glucose 6-phosphate dehydrogenase
changes in liver function and inflammation of the liver (hepatitis)
destruction of liver cells (cytolytic hepatitis) which can lead to decreased liver function (acute liver failure)
decreased kidney function (acute kidney failure), inflammation of the kidneys (interstitial nephritis), blood in the urine (haematuria), lack of urine production (anuria)
gastrointestinal disorders
dizziness
disorders of the arteries of the heart of an allergic nature (Kounis syndrome)
narrowing of the bronchi with difficulty in breathing (bronchospasm).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Suppositories: store below 30 ° C.

Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other Information

What Fluental contains

Fluental 300 mg + 150 mg tablets

The active ingredients are paracetamol and sobrerol. One tablet contains 300 mg of paracetamol and 150 mg of sobrerol.
The other ingredients are: calcium hydrogen phosphate dihydrate, maize starch, talc, magnesium stearate, povidone, microcrystalline cellulose, sodium starch glycolate (Type A).

Fluental Adults 500 mg + 200 mg suppositories

The active ingredients are paracetamol and sobrerol. One suppository contains 500 mg of paracetamol and 200 mg of sobrerol.
The other components are: triglycerides, medium chain.

Fluental Children 250 mg + 100 mg suppositories

The active ingredients are paracetamol and sobrerol. One suppository contains 250 mg of paracetamol and 100 mg of sobrerol.
The other ingredients are: triglycerides i, medium chain.

Fluental 12.8 mg / ml + 8 mg / ml syrup

The active ingredients are paracetamol and sobrerol. 100 ml of syrup contains 1.28 g of paracetamol and 0.8 g of sobrerol.
The other ingredients are: propylene glycol, glycerol, carmellose sodium, sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, 96 percent ethanol, saccharin, E 150, ethylvanillin, cardamom flavoring, disodium phosphate dodecahydrate, sodium phosphate dihydrogen dihydrate, purified water.

What Fluental looks like and contents of the pack

Fluental comes in the form of suppositories, tablets and syrup.

The contents of the package are:

Adult suppositories Box of 6 and 10 suppositories
Suppositories for children Box of 6 and 10 suppositories
Tablets Box of 15 tablets
Syrup Bottle of 150 ml.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information about Fluental can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

FLUENTAL

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Fluental 300 mg + 150 mg tablets

One tablet contains:

active principles: paracetamol 300 mg, sobrerol 150 mg.

Fluental Children 250 mg + 100 mg suppositories

Each suppository contains:

active principles: paracetamol 250 mg, sobrerol 100 mg.

Fluental Adults 500 mg + 200 mg suppositories

Each suppository contains:

active principles: paracetamol 500 mg, sobrerol 200 mg.

Fluental 12.8 mg / ml + 8 mg / ml syrup

100 ml of syrup contain:

active principles: paracetamol 1.28 g, sobrerol 0.8 g

Excipients with known effects: sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, 96 percent ethanol, carmellose sodium, disodium phosphate dodecahydrate, sodium phosphate dihydrogen dihydrate.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Tablets; suppositories; syrup.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Symptomatic treatment of acute febrile processes of the respiratory system.

04.2 Posology and method of administration

Adult suppositories: 2 suppositories pro / day

Suppositories for children: 2 suppositories pro / day

Adult tablets: 2 - 4 tablets pro / day

Syrup: 4 - 6 teaspoons per / day

The product is contraindicated in patients with severe hepatocellular insufficiency and in patients with severe renal impairment (see section 4.3).

Administer with caution in subjects with renal or hepatic insufficiency (see section 4.4).

Do not exceed the maximum total daily dosage.

04.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1;

Patients with manifest insufficiency of glucose-6-phosphate dehydrogenase;

Patients with severe haemolytic anemia;

Severe hepatocellular insufficiency;

Severe changes in kidney function;

Severe changes in the blood count.

04.4 Special warnings and appropriate precautions for use

High or prolonged doses of the product can cause even serious alterations to the kidney and blood crase and a high-risk liver disease.

Not to be used outside the acute febrile phase.

Do not administer for more than 3 consecutive days without consulting your doctor.

For administration to children under 3 years of age, consult your doctor.

In patients treated with anticoagulants, the product should be administered at a reduced dosage.

Administer with caution in subjects with renal or hepatic insufficiency.

During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses.

Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short-term treatment and in patients with no pre-existing hepatic dysfunction (see section "Undesirable effects").

Caution is advised in patients with a history of sensitivity to aspirin and / or non-steroidal anti-inflammatory drugs (NSAIDs).

Serious skin reactions: Life-threatening reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (NET) and acute generalized exanthematous pustulosis have been reported with the use of paracetamol. Patients should be informed of the signs and symptoms and closely monitored for skin reactions. If symptoms or signs of Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis (e.g. progressive skin rash associated with blistering or mucosal lesions) occur, the patient should immediately discontinue paracetamol treatment and consult a physician.

The use of Fluental, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women who intend to become pregnant.

The administration of Fluental should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

Instruct the patient to contact the physician before associating any other medication. See also the heading "Interactions with other medicinal products and other forms of" interaction ".

Fluental syrup contains 1.25 vol% ethanol (alcohol), eg. up to 300 mg per serving, equivalent to 7.5 ml of beer, 3.1 ml of wine per serving.

It can be harmful to alcoholics.

To be taken into consideration in pregnant or lactating women, children and high-risk groups such as people with liver disease or epilepsy.

Fluental syrup contains up to 9 g of sucrose per serving. To be taken into consideration in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.

Fluental syrup contains methyl parahydroxybenzoate and propyl parahydroxybenzoate: they can cause allergic reactions (even delayed).

Fluental syrup can contain up to 2 mmol sodium per dose. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.

04.5 Interactions with other medicinal products and other forms of interaction

Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monooxygenases or in case of exposure to substances that can have this effect (for example cimetidine).

The risk of paracetamol toxicity may be increased in patients taking other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as some antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin and alcohol.

The administration of paracetamol can interfere with the determination of uricaemia (by the phosphotungstic acid method) and with that of blood glucose (by the glucose-oxidase-peroxidase method).

Drugs that slow down gastric emptying (eg propantheline) can reduce the absorption rate of paracetamol, delaying its therapeutic effect; on the contrary, drugs that increase gastric emptying speed (eg metoclopramide, domperidone) lead to an increase in absorption rate.

Paracetamol may increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists. Patients taking acetaminophen and vitamin K antagonists should be monitored for appropriate clotting and bleeding.

The presence of paracetamol in the product increases the plasma rates of aspirin and chloramphenicol.

The simultaneous use of NSAIDs or opioids can lead to a reciprocal enhancement of the analgesic effect.

Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis in patients with risk factors for glutathione depletion.

Paracetamol increases the AUC of ethinylestradiol by 22%.

Paracetamol can reduce the plasma concentration of lamotrigine.

04.6 Pregnancy and breastfeeding

In case of pregnancy or breastfeeding use only in case of real need under the direct supervision of the doctor.

04.7 Effects on ability to drive and use machines

Due to the possible onset of dizziness, the product may impair the ability to drive or use machines.

04.8 Undesirable effects

Skin and subcutaneous tissue disorders

Erythema, urticaria, rash, fixed drug eruption.

Very rare cases of severe skin reactions such as toxic epidermal necrolysis (NET), Stevens-Johnson syndrome (SSJ) and acute generalized exanthematous pustulosis have been reported (see section 4.4 Special warnings and appropriate precautions for use).

Disorders of the immune system

Hypersensitivity reactions such as angioedema, larynx edema, anaphylactic shock.

Disorders of the blood and lymphatic system

Thrombocytopenia, neutropenia, leukopenia.

Agranulocytosis, haemolytic anemia in patients with basic glucose 6-phosphate dehydrogenase deficiency.

Hepatobiliary disorders

Changes in liver function and hepatitis.

Cytolytic hepatitis which can lead to acute liver failure.

Renal and urinary disorders

Acute renal failure, interstitial nephritis, haematuria, anuria.

Gastrointestinal disorders

Gastrointestinal reactions.

Ear and labyrinth disorders

Dizziness.

Cardiac pathologies

Kounis syndrome.

Respiratory, thoracic and mediastinal disorders

Bronchospasm.

The reported undesirable effects require the interruption of treatment and the institution of an appropriate therapy.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose

Symptoms of acetaminophen overdose are paleness, nausea, vomiting, anorexia and abdominal pain and generally appear during the first 24 hours after acetaminophen overdose.

Paracetamol overdose can cause hepatic cytolysis which can lead to hepatocellular failure, gastrointestinal bleeding, metabolic acidosis, encephalopathy, coma and death. Elevated hepatic transaminase, lactate dehydrogenase and bilirubin levels with decreased prothrombin levels may occur 12 to 48 hours after acute overdose.

Overdose can also lead to pancreatitis, acute renal failure and pancytopenia.

In severe cases, hepatic insufficiency due to cellular necrosis can occur.

Regarding sobrerol, there are no data regarding symptoms of overdose in the literature.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: paracetamol, combinations excluding psycholeptics, ATC code: N02BE51.

Sobrerol has a fluidifying and regulating action on the secretions of the respiratory system and facilitates their removal through a better mucociliary clearance.

Paracetamol is a drug with rapid and effective antipyretic and analgesic activity which is accompanied by excellent tolerability even at the gastric level. Its action is expressed through a direct effect on the pain centers and thermoregulation probably through the inhibition of PG-synthase.

The two drugs have an evident synergistic behavior with modifications of the thermal curve favorable to the association compared to the controls treated with paracetamol alone.

05.2 Pharmacokinetic properties

Absorption: sobrerol is rapidly absorbed orally by the first tracts of the "gastrointestinal tract. Maximum peak at 60". In humans, paracetamol is rapidly absorbed from the gastrointestinal tract and varies according to whether it is taken on an empty or full stomach.

Distribution: sobrerolo is rapidly distributed.

The rapid distribution is confirmed by the elevated sobrerol levels found in the bronchial mucus.

In humans, the plasma half-life of sobrerol administered for i.v. is 1.60 hours while in mucus the aforementioned time is 10.82 hours.

Orally, the plasma half-life of sobrerol is 2.39 hours and 2.98 hours in bronchial mucus.

In the "man", the intake of 1 g of paracetamol on an empty stomach determines a concentration curve whose maximum from 20 to 28.7 mcg / ml, occurs after 20 - 30 "and is followed by a progressive decrease between the fourth and the eighth hour.

The trend of the curve after the rectal administration of one gram of paracetamol also shows an initial peak of 7.4 mcg / ml after 2 hours showing a faster absorption than aminophenazone.

The half-life of paracetamol, which after absorption is distributed uniformly in all organs, ranges from 122 "to 165", but tends to be prolonged in the presence of liver disease.

Biotransformation: the biotransformation of sobrerol in man has two types of reaction: that in phase I in which sobrerol is passed to carvone and that in phase II constituted by conjugation with glucuronic acid.

A total of 9 metabolites have been identified in humans and animals.

Paracetamol is metabolised in the liver, for the most part, it is combined with glucuronic acid and sulphates.

Elimination: in humans, sobrerol is eliminated almost exclusively via the kidneys in the form of: free sobrerol, glucurono-conjugated sobrerol and carvone.

Paracetamol administered both orally and rectally is eliminated mainly via the urine both in the form of metabolites and as unchanged substance and its elimination is almost complete within 24 hours.

05.3 Preclinical safety data

Acute toxicity: LD50 rats 2480 mg / kg os;

Chronic toxicity: it has been observed that by administering orally, for a period of 6 months, Fluental at high and increasing doses from 3 to 10 times higher than those used in man (doses varying therefore from 42 to 144 mg / kg / day ), the animals showed no signs of suffering so much that one could speak of a virtual absence of chronic toxicity.

Teratogenesis: research carried out on rabbits and rats indicates that Fluental did not exert any negative action on reproductive processes, on the progress of pregnancy and on the appearance of newborns.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Tablets

Calcium hydrogen phosphate dihydrate, corn starch, talc, magnesium stearate, povidone, microcrystalline cellulose, sodium starch glycolate (Type A).

Suppositories Adults and Children

Triglycerides, s medium chain.

Syrup

Propylene glycol, glycerol, carmellose sodium, sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, 96 percent ethanol, saccharin, E150, ethylvanillin, cardamom flavoring, disodium phosphate dodecahydrate, sodium phosphate dihydrogen dihydrate, purified water.