Allergosan 25 mg (20 tablets)

The dose and duration of treatment are determined by your doctor. It is important that you take the medicine as prescribed by your doctor. You should not change the dose or stop the treatment without first consulting your doctor, even if you feel well. Try to take the medicine at the same time each day. Method of administration: the tablets are taken with food, with water,

Adults and children over 14 years: 1 tablet 3-4 times a day. The maximum dose is 6 tablets a day, divided into 3 doses of 2 tablets.

Children 5 to 14 years: half a tablet Allergosan (12.5 mg) 3 times a day.

Children under 5 years of age: this formulation is not suitable for children under 5 years of age.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.

If you take more Allergosan than you should

If you take more than the prescribed dose, you may feel dizzy, drowsy, dizzy, nausea, vomiting, fever, reddening of the skin. Consult your doctor immediately. If you miss an allergy to Allergosan.

If you forget to take a dose, take it as soon as possible

If it is almost time for your next dose, take it as usual, skipping the missed dose. Do not take a double dose to make up for a forgotten dose. Continue to take the medicine as prescribed by your doctor.

When should you not use Allergosan?

• Hypersensitivity to the drug or excipients;
• Pregnancy and lactation;
• Active gastro-duodenal ulcer;
• Pyloroduodenal stenosis (narrowing of the stomach outlet);
• Asthma attack.

Before starting treatment with Allergosan:

• Tell your doctor if you have any chronic illness, if you are hypersensitive to other medicines or medicines, or if you are taking other medicines.
• Tell your doctor if you have hyperthyroidism (increased thyroid function), cardiovascular disease, liver disease, glaucoma (increased intraocular pressure), prostate adenoma and bronchial asthma, or are undergoing allergen desensitization.
• Elderly patients (over 65 years of age) are more likely to experience dizziness, sedation and hypotension.
• Treatment with chloropyramine in children should be carried out under medical supervision, as they have more common side effects – manifestations of agitation.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or planning to become pregnant. Be sure to talk to your doctor before taking any medication during pregnancy.

The use of Allergosan during pregnancy and lactation is contraindicated.

Effects on ability to drive and use machines

When using Allergosan, drowsiness, incoordination and delayed reactions may occur. In case of need for treatment with Allergosan for drivers and machine operators, it is recommended to stop the activities that require increased attention and speed of reactions.

Excipient information

Due to the presence of wheat starch in the tablet, the product is unsuitable for people with gluten intolerance (gluten enteropathy).

Interaction with other medicines

Please tell your doctor about ALL medicines you are currently taking or have taken recently, whether prescribed by a doctor or bought without a prescription.

This is important because Allergosan may change the activity of some medicines or, conversely, some medicines may change its effects. Concomitant use of Allergosan with atropine and atropine-like agents may increase the risk of adverse reactions such as urinary retention, constipation, dry mouth.

It is also possible to enhance the effect of sedatives, hypnotics, other anti-allergic (antihistamines) and alcohol, therefore such combinations with Allergosan should be avoided. Tricyclic antidepressants (amitriptyline, imipramine) may increase the sedative effect and its side effects. Concomitant use with MAO inhibitors (moclobemide) may cause an increase in side effects. An interval of two weeks is required after discontinuation of monoamine oxidase inhibitors.

Side effects:

Like all medicines, Allergosan can have side effects. However, they are not necessarily seen in all patients, so you may not get any reaction.

• Rarely, weakness, fatigue, drowsiness, decreased attention and incoordination, muscle weakness, dry mouth, dizziness, nausea, vomiting, abdominal pain, constipation, diarrhea, loss of appetite, itching, rash, photosensitivity may occur. lowering of blood pressure, palpitations, difficulty urinating, urinary retention. They usually go away during treatment. Weight gain is sometimes observed due to increased appetite, visual disturbances and increased intraocular pressure, rarely hypersensitivity.
• In rare cases, paradoxical reactions are possible (increased excitability, nervousness, irritability, insomnia), more frequent and more pronounced in children and the elderly. If you get side effects, including those not mentioned in this leaflet, tell your doctor.

Allergosan tablets 25 mg * 20 SOPHARMA

Package leaflet: user
information ALLERGOSAN 25 mg coated tablets

chloropyramine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may have to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Don’t pass it on to other people. It can harm them, even though the signs of their illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Allergosan tablets are and what it is used
for 2. What you need to know before you take Allergosan tablets
3. How to take Allergosan tablets
4. Possible side effects
5. How to store Allergosan tablets
6. Contents of the pack and other information

1. What Allergosan tablets are and what it is used for

• Allergosan tablets contain the active substance chloropyramine hydrochloride, which belongs to the group of classic antihistamines for the treatment of allergic reactions. It suppresses the effects of histamine, which is formed in the body and determines allergic reactions.
• Allergosan tablets are used for the symptomatic treatment of seasonal allergic rhinitis and conjunctivitis, urticaria, dermography, contact dermatitis, drug and food allergies, insect bites and pruritus (itching).
• Allergosan tablets can also be used as an adjunct to the treatment of systemic anaphylactic reactions and angioedema (sudden life-threatening allergic reaction, sudden signs of allergy such as rash, itching or urticaria on the skin, swelling of the face, lips, tongue, throat or other parts of the body, shortness of breath, difficulty swallowing, wheezing or difficulty breathing), but only after basic treatment (with adrenaline).

2. What you need to know before you take Allergosan tablets

Do not take Allergosan tablets:

• if you are allergic to the active substance or any of the other ingredients (listed in section 6);
• in conditions of asthma attack;
• if you are pregnant or breast-feeding;
• in newborns or premature infants.

This medicine can be obtained without a doctor’s prescription in adults and children over 14 years of age. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

For children aged 6 to 14 years, you can only get a prescription.

If you need further information or advice, ask your pharmacist.

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before taking Allergosan if:

• have hyperthyroidism (increased thyroid function);
• you have cardiovascular disease;
• you have liver disease;
• you have glaucoma (increased intraocular pressure);
• you have adenoma (benign tumor) of the prostate gland;
• you suffer from bronchial asthma;
• you suffer from gastroesophageal reflux disease (passage of gastric contents into the esophagus);

In elderly patients (over 65 years of age) or debilitated patients, the possibility of dizziness, sedation (sedation without inducing sleep) and lower blood pressure is greater.

Children and adolescents:

Treatment with chloropyramine in children should be carried out under medical supervision, since they have more frequent adverse effects – manifestations of agitation.

Other medicines and Allergosan tablets:

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

• Concomitant use of Allergosan with atropine, buscolysin or other atropine-like agents may increase the risk of side effects such as urinary retention, constipation, dry mouth. It is also possible to enhance the effect of sedative (sedative, tranquilizers), sleeping pills, painkillers (narcotic analgesics), other antiallergic (antihistamine) drugs, alcohol and alcohol-containing products, therefore such combinations with Allergosan should be avoided.
• Tricyclic antidepressants (amitriptyline, imipramine) may enhance its sedative effect and side effects.
• Allergosan may mask the effects of drugs that cause hearing impairment.
• Concomitant use with MAO inhibitors (moclobemide) may cause an increase in adverse reactions. To start treatment with Allergosan, an interval of 2 weeks after stopping MAO inhibitors is required.
• Allergosan should not be taken while conducting skin tests to detect allergens. The latter can be carried out several days after stopping treatment with Allergosan.

Allergosan tablets with food, drink and alcohol:

• Tablets are taken during meals with water.
• Avoid alcohol during treatment with Allergosan.

Pregnancy, breast-feeding and fertility:

• 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 Allergosan tablets during pregnancy and lactation is contraindicated.
• If treatment is needed, breast-feeding should be discontinued.

Driving and using machines:

• Allergosan has a moderate influence on the ability to drive and use machines When using Allergosan tablets, drowsiness, coordination disorder and slowing down reactions are possible.
• If it is necessary to treat drivers of vehicles and machine operators with Allergosan, it is recommended to stop activities requiring increased attention and speed of reactions.

Allergosan tablets contain lactose and sucrose as excipients.

• If your doctor has told you that you have an intolerance to some sugars, ask him or her before taking Allergosan.

Allergosan tablets contain wheat starch.

• It is suitable for people with celiac disease (gluten enteropathy).
• Patients with wheat allergy (other than celiac disease) should not take this product.

3. How to take Allergosan tablets

Always take this medicine exactly as your doctor or pharmacist has told you or exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults: 1 tablet 3-4 times a day. The maximum dose is 6 tablets per day, divided into 3 doses of 2 tablets.

Use in children and adolescents:

• Children over 14 years: 1 tablet 3-4 times a day. The maximum dose is 6 tablets per day, divided into 3 doses of 2 tablets.
• Children from 6 to 14 years: 1/2 tablet 3 times a day.
• Children under 6 years: this dosage form is not suitable for children under 6 years of age.
• The maximum daily dose is 2 mg/kg body weight.

Patients are elderly (over 65 years) and debilitated patients:

• The use of the medicinal product in this category of patients requires caution due to the manifestation of increased sensitivity to antihistamines in relation to their adverse effects.

Patents with liver injuries:

• In patients with impaired liver function, it is recommended to use a lower than recommended daily dose.

Patients with renal impairment:

• In patients with renal insufficiency, a reduction in the recommended daily dose is necessary.

Method of administration:

• Tablets are taken whole, with a meal, with water.

Duration of treatment:

• The duration of treatment depends on the type and expression of symptoms.

If you take more Allergosan tablets than you should:

• If you take a dose greater than prescribed, you may feel dizziness, drowsiness, suppression of reflexes and active attention; Psychomotor excitement, convulsions and coma are also possible, rarely – an increase in temperature and redness of the skin.
• In children – pupil dilation, increase in temperature and redness of the skin, coordination disorder, anxiety, agitation, hallucinations, seizures, fast heartbeat, coma. Ask your doctor immediately. Treatment is carried out in hospital conditions

If you forget to take Allergosan tablets:

• Do not take a double dose to make up for a forgotten dose. If you miss a dose, take it as soon as possible. If it’s almost time for your next dose, take it as usual, skipping the dose you forgot. Continue to take the medicine as prescribed by your doctor. Ask your doctor immediately. Treatment is carried out in hospital conditions

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

4. Possible side effects

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

Rare (affects less than 1 in 1,000 patients)

• leukopenia (reduced white blood cells),
• agranulocytosis (absence of a type of white blood cell),
• haemolytic anaemia (destruction of red blood cells),
• other blood disorders, sedation,
• fatigue
• dizziness
• ataxia (violation of coordination),
• nervousness
• Tremor
• Seizures
• headache
• Euphoria
• encephalopathy (brain disease),
• blurred vision,
• • increased intraocular pressure and glaucoma attack,
• Arrhythmia
• tachycardia (healthy heartbeat),
• decrease in blood pressure,
• difficulty urinating,
• urinary retention.

Very rare (affects less than 1 in 10,000 patients)

• dry mouth,
• nausea
• Vomiting
• constipation
• Diarrhea
• lack of appetite or increased appetite,
• pain and discomfort in the stomach,
• photo sensitivity.

Not known (cannot be estimated from the available data)

• myopathy (muscle pain, muscle sensitivity or weakness),
• allergic reactions.

Additional side effects in children and adolescents

In rare cases, paradoxical reactions (increased excitability, nervousness, irritability, insomnia), more frequent and more pronounced in children and elderly patients are possible.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Allergosan tablets

• Store in the original package at a temperature below 25°C.
• Keep out of the reach of children.
• Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Allergosan tablets contains:

• The active substance is chloropyramine hydrochloride 25 mg per tablet.
• The other ingredients are: lactose monohydrate, wheat starch: cellulose, microcrystscha (type 101); carmellose sodium, talc, magnesium stearate; silica, colloid,day anhydrous Envelope coating: basic butylmethacrylate copolymer, polysorbate 80, talc, titanium dioxide (E171), sucrose, gelatin; Arabic gum dried by sputtering; Glycerol.

What Allergosan tablets look like and contents of the pack include:

• Round, biconvex tablets with straight shape and glossy surface, white odorless.
• 20 tablets in a blister of solid, colourless, transparent PVC/aluminium foil; 1 blister per carton, together with a leaflet.

Marketing authorisation holder and manufacturer:

SOPHARMA AD, Bulgaria