ANOSIN 10 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Anosin, 10 mg, hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Anosin and what is it used for
4. Important information before taking Anosin
   1. When not to take Anosin:
   2. Warnings and precautions
   3. Children and adolescents
   4. Anosin and other medicines
   5. Anosin with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Anosin contains lactose monohydrate
5. How to take Anosin
   1. Use in adults and adolescents over 12 years of age
   2. Use in the elderly
   3. Taking a higher dose of Anosin than recommended
   4. Missing a dose of Anosin
   5. Stopping Anosin treatment
6. Possible side effects
   1. Reporting side effects
7. How to store Anosin
8. Package contents and other information
   1. What Anosin contains
   2. What Anosin looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:

Leaflet attached to the packaging: patient information

Anosin, 10 mg, hard capsules

Phenylephrine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Anosin and what is it used for
• 2. Important information before taking Anosin
• 3. How to take Anosin
• 4. Possible side effects
• 5. How to store Anosin
• 6. Package contents and other information

1. What is Anosin and what is it used for

Anosin contains phenylephrine, which, by causing the contraction of small blood vessels in the nasal mucosa, reduces its swelling, making it easier to breathe and reducing the amount of nasal discharge. The medicine is taken orally and is intended for use in adults and adolescents over 12 years of age. The medicine is used for:

• temporary relief of symptoms of nasal mucosa swelling (cold) occurring in colds and flu;
• allergic rhinitis (hay fever).

2. Important information before taking Anosin

When not to take Anosin:

• cardiovascular disorders such as: hypertension, arrhythmias, coronary artery disease, cerebrovascular disorders;
• pheochromocytoma;
• diabetes;
• angle-closure glaucoma;
• hyperthyroidism;
• prostatic hyperplasia;
• while taking certain medicines used to treat low blood pressure and depression (from the group of monoamine oxidase inhibitors (MAO) and within 14 days of stopping their use;
• during pregnancy or breastfeeding;
• in children under 12 years of age.

Warnings and precautions

Before starting Anosin, the patient should discuss it with their doctor or pharmacist if they have:

• Raynaud's syndrome (pallor, followed by cyanosis of the fingers, toes, earlobes, and nose tip, often under the influence of cold or emotions);
• vascular arteritis;
• respiratory failure or bronchial asthma; Use with caution in patients taking beta-adrenergic receptor antagonists (medicines used, for example, in the treatment of hypertension).

Children and adolescents

The medicine should not be used in children under 12 years of age.

Anosin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The medicine should not be used at the same time as other medicines containing:

• phenylephrine or pseudoephedrine (medicines used in the symptomatic treatment of rhinitis, i.e., colds);
• other active substances with a similar action to phenylephrine or MAO inhibitors (medicines used in low blood pressure and depression).

The patient should consult their doctor before using Anosin with:

• indomethacin (a pain reliever and anti-inflammatory used in rheumatic diseases);
• beta-adrenergic receptor antagonists (medicines used in hypertension and cardiovascular diseases);
• tricyclic antidepressants (medicines used in mental disorders);
• guanethidine, mecamylamine, reserpine (medicines used in the treatment of hypertension) or methyldopa.

It is not recommended to use phenylephrine at the same time as ergot alkaloids and digitalis glycosides.

Anosin with food and drink

Food does not affect the absorption of the medicine. The medicine can be taken regardless of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Pregnancy Do not use during pregnancy. Breastfeeding Do not use during breastfeeding. Fertility There is no data on the effect of phenylephrine on human fertility.

Driving and using machines

While taking Anosin, the patient should be cautious when driving vehicles and operating machines.

Anosin contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Anosin

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse. Oral administration.

Use in adults and adolescents over 12 years of age

1 hard capsule every 4 to 6 hours (maximum 4 capsules per day). The medicine should not be used in children under 12 years of age.

Use in the elderly

There is no need to reduce the dose in elderly patients. The medicine should not be used for more than 7 days without consulting a doctor.

Taking a higher dose of Anosin than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor. In case of overdose, rapid heart rate, increased blood pressure, vasodilation leading to a significant drop in blood pressure, and difficulty breathing may occur. If the overdose occurred no more than 1 hour ago, the patient should induce vomiting and consult their doctor, as specialized treatment in a hospital setting may be necessary. Treatment involves gastric lavage and administration of beta-adrenergic blockers. In severe poisoning, monitoring of vital functions, respiratory support, and circulation in an intensive care setting may be necessary. The doctor will decide on the treatment method and the need to monitor vital functions.

Missing a dose of Anosin

The patient should not take a double dose to make up for a missed dose.

Stopping Anosin treatment

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Anosin can cause side effects, although not everybody gets them. The frequency of side effects is classified as follows:

Frequent(may occur in 1 to 10 out of 100 people):

• gastrointestinal disorders: nausea, vomiting, digestive disorders;
• metabolism and nutrition disorders: loss of appetite.

Rare(may occur in 1 to 10 out of 10,000 people):

• skin and subcutaneous tissue disorders: itching, hives, pallor;
• immune system disorders: allergic reactions and hypersensitivity, including symptoms of anaphylactic shock (rapid breathing, confusion, pallor, low blood pressure, sweating, oliguria, weakness, and fainting) and bronchospasm;
• cardiac disorders: tachycardia, arrhythmias, palpitations;
• vascular disorders: increased blood pressure.

Very rare(may occur less frequently than 1 in 10,000 people):

• nervous system disorders: tremors, dizziness, and headaches;
• psychiatric disorders: anxiety, agitation, nervousness, insomnia, irritability, hallucinations;

Frequency not known(cannot be estimated from available data):

• renal and urinary disorders: urinary retention.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Anosin

Store at a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Anosin contains

• The active substance of the medicine is phenylephrine. One hard capsule contains 10 mg of phenylephrine in the form of 12.2 mg of phenylephrine hydrochloride.
• Other ingredients are: Filler:lactose monohydrate, corn starch, maize starch, magnesium stearate. Capsule shell:gelatin, titanium dioxide.

What Anosin looks like and what the package contains

Anosin is a hard white capsule, packaged in aluminum/PVC/PVDC blisters and a cardboard box. 1 package contains 20 hard capsules (2 blisters of 10 capsules each).

Marketing authorization holder and manufacturer

Pharmaceutical and Chemical Company "Synteza" Sp. z o.o., ul. Św. Michała 67/71, 61-005 Poznań, tel. 61 879-20-81. For more detailed information, please contact the local representative of the marketing authorization holder: Poland, Pharmaceutical and Chemical Company "Synteza" Sp. z o.o., ul. Św. Michała 67/71, 61-005 Poznań, tel. 61 879-20-81.

Date of the last update of the leaflet: