POLARAMIN 6 mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

1. Polaramin 2 mg/5 ml syrup
   1. What is Polaramin syrup and what is it used for
   2. What you need to know before taking Polaramin syrup
   3. How to take Polaramin syrup
   4. Possible side effects
   5. How to store Polaramin syrup
   6. Contents of the pack and other information
2. Polaramin 1% cream
   1. What Polaramin 1% cream is and what it is used for
   2. What you need to know before using Polaramin 1% cream
   3. How to use Polaramin 1% cream
   4. Possible side effects
   5. How to store Polaramin 1% cream
   6. Contents of the pack and other information

Polaramin 2 mg/5 ml syrup

Desclorfeniramina maleate

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is Polaramin syrup and what is it used for

Polaramin syrup contains the active ingredient deslorfeniramine maleate, which belongs to a class of
medicines called “antihistamines”.
Polaramin syrup helps to reduce allergic symptoms by blocking the effects of a substance called “histamine”
which is produced by the human body when you have allergies.
This medicine is used for the treatment of symptoms of diseases caused by seasonal pollen (such as rhinitis
(runny nose and nasal itching), conjunctivitis (red, burning and
watery eyes), urticaria (itching and small spots on the skin), itching and vasomotor rhinitis (a form
of non-allergic rhinitis).
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of
treatment.

2. What you need to know before taking Polaramin syrup

Do not take Polaramin syrup

• If you are allergic to deschlorpheniramine maleate, to other similar antihistamines or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from:
• glaucoma (high pressure inside the eye);
• prostatic hypertrophy (enlargement of the prostate);
• bladder neck obstruction (narrowed bladder neck, causing difficulty in urination);
• pyloric and duodenal stenosis (narrowing of the outlet valve of the stomach and the first part of the intestine);
• narrowing of other parts of the gastrointestinal and urogenital tract;
• epilepsy (seizures).
• For the treatment of diseases of the lower respiratory tract, including bronchial asthma.
• If you are taking monoamine oxidase inhibitors (so-called MAOIs, medicines used to treat depression) at the same time or within two weeks of stopping such treatment.
• If you are under 12 years of age.
• If you are in the last three months of pregnancy (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking Polaramin syrup.
Polaramin syrup may cause excitability, especially in children (see “Possible side effects”).
Stop using antihistamines (such as Polaramin syrup) approximately 48 hours before performing skin tests,
as antihistamine medicines can prevent or reduce positive reactions.

Use this medicine only after consulting your doctor if you have one or more of the following
conditions:

• cardiovascular diseases (of the heart and blood vessels),
• high blood pressure,
• hyperthyroidism (overactive thyroid),
• increased ocular pressure (increased pressure in the eye).

Consult your doctor also in cases where these disorders have occurred in the past.
In elderly subjects, the dose of Polaramin syrup should be established by the doctor (see “Possible side effects”).

Children and adolescents
This medicine should not be taken by children and adolescents under the age of 12.

Other medicines and Polaramin syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Polaramin syrup if you are undergoing therapy with monoamine oxidase inhibitors
(so-called MAOIs, medicines used to treat depression) or within two weeks of stopping such treatment, or if you are being treated with other antihistamines, oral anticoagulants (medicines
used to thin the blood), tricyclic antidepressants (a type of medicine used to treat
depression), barbiturates (medicines used to treat epilepsy) or other central nervous system depressants (see “Do not take Polaramin syrup”).
If you are taking Polaramin, this may mask undesirable effects on the ear due to antibiotics.

Polaramin syrup with food, drinks and alcohol
Do not drink alcohol during treatment with Polaramin syrup.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
If you are pregnant (first six months) or are breastfeeding, use Polaramin syrup only after
consulting your doctor and assessing the risk/benefit ratio with him.
Do not use the medicine in the last three months of pregnancy (see “Do not take Polaramin syrup”) because
newborns and premature babies may develop serious adverse reactions to antihistamines.

Driving and operating machinery
Because the most common side effect of Polaramin syrup is drowsiness, do not drive
vehicles or operate dangerous machinery while taking the medicine.

Polaramin syrup contains sugar: keep this in mind if you suffer from diabetes or are following a low-calorie diet (poor in calories).

Polaramin syrup contains sucrose and sorbitol: if your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

Polaramin syrup contains methylparaben and propylparabenwhich may
cause allergic reactions (even delayed).

Polaramin syrup contains propylene glycol: may cause symptoms similar to those caused by alcohol.

Polaramin syrup contains ethyl alcohol: for athletes, the use of medicines containing ethyl alcohol
may result in a positive doping test in relation to the alcohol concentration limits indicated by
some sports federations.

3. How to take Polaramin syrup

Take this medicine following the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults and children over 12 years of age is 1 teaspoon (5 ml) 3-4 times a day.
Caution: do not exceed the indicated doses without your doctor's advice. Use this medicine only for short
periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in the
characteristics of the disorder.
You can reduce the undesirable effects on the stomach and intestines (anorexia, nausea, vomiting and diarrhoea)
by taking Polaramin syrupwith meals.

If you take more Polaramin syrup than you should
In case of accidental ingestion/intake of an excessive dose of Polaramin syrup, immediately inform your
doctor or go to the nearest hospital.
You must use Polaramin syrup only at the recommended doses. Overdosage can be very dangerous,
especially in children.
If you take an excessive dose, you may experience sedation (drowsiness), apnea (cessation of breathing),
cyanosis (bluish discoloration of the skin and mucous membranes), decreased state of consciousness, arrhythmias (irregular
heartbeat), cardiovascular collapse (drop in blood pressure), insomnia, hallucinations,
tremors or convulsions, up to death. Dizziness, tinnitus (ringing or buzzing in the
ears), difficulty of movements, blurred vision and hypotension (low blood pressure) may also be present. In
children, it is more common to observe excitation, dry mouth, fixed and dilated pupil, flushing, temperature increase and gastrointestinal symptoms.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to take Polaramin syrup
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
At usual doses, the most common side effects are:

• sedation (drowsiness),
• asthenia (feeling of weakness),
• easy fatigue,
• difficulty in movements,
• difficulty in vision (visual problems),
• dizziness,
• ringing in the ears.

Additional side effects in children
In children, in particular, euphoria (exaggerated sense of well-being), nervousness, tremor and
insomnia are possible, and - at high doses - convulsions.
Other frequent side effects are:

• dryness of the mouth, throat and nose,
• constipation,
• difficulty urinating and urinary retention,
• reduction and thickening of bronchial secretions (mucus), accompanied by a feeling of chest tightness and difficulty breathing.

The following side effects have also been reported:

• reactions affecting blood cells (hematological),
• urticaria (itching and small spots on the skin),
• skin rash,
• anaphylactic shock (severe allergic reaction, potentially fatal),
• photosensitization (development of excessive skin reactivity to sunlight),
• excessive sweating,
• chills.

At usual doses Polaramin syrup has no effects on the heart and circulation. However, in the elderly and in sensitive
subjects, headache, decreased blood pressure, increased heart rate, palpitations (feeling of a fast or irregular
heartbeat) and extrasystoles (irregular heartbeat) are possible.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Polaramin syrup

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Polaramin syrup contains

• The active ingredient is deslorfeniramine maleate. 100 ml of syrup contains 40 mg of deslorfeniramine maleate.
• The other ingredients are: sodium chloride, disodium citrate dihydrate, sucrose, sorbitol70%, propylene glycol, methylparaben, propylparaben, citric acid, apricot flavour, ethyl alcohol, orange flavour, menthol, sodium hydroxide, purified water.

Description of the appearance of Polaramin syrup and contents of the pack
Polaramin syrup – 100 ml bottle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
BAYER S.p.A. – Viale Certosa, 130 – 20156 Milano

Sales Concessionaire
Essex Italia S.r.l. - via Vitorchiano, 151 - 00189 Roma

Manufacturer
Schering-Plough Labo N.V. – Industriepark, 30 – Zone A – B-2220 Heist-op-den-Berg (Belgium)

Polaramin 1% cream

Desclorfeniramina maleate

Read this leaflet carefully before you use this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

• 1. What Polaramin 1% cream is and what it is used for
• 2. What you need to know before you use Polaramin 1% cream
• 3. How to use Polaramin 1% cream
• 4. Possible side effects
• 5. How to store Polaramin 1% cream
• 6. Contents of the pack and other information

1. What Polaramin 1% cream is and what it is used for

Polaramin 1% cream contains the active ingredient deslorfeniramine maleate, which belongs to a class of
medicines called “antihistamines”.
Polaramin 1% cream helps to reduce allergic symptoms by blocking the effects of a substance called “histamine”
which is produced by the human body when you have allergies.
Polaramin 1% cream is a medicine that exerts an antihistamine action directly at the skin level,
inhibiting redness, burning and itching.
This medicine is used for the local treatment of symptoms of pruritic dermatitis (skin diseases that
cause itching), solar erythema (redness characterized by itching, pain, burning sensation and presence of
blisters following excessive exposure to the sun) and insect bites.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after a short period of
treatment.

2. What you need to know before using Polaramin 1% cream

Do not use Polaramin 1% cream

• if you are allergic to desclorpheniramine maleate, to other similar antihistamines or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Polaramin 1% cream.
Stop using Polaramin 1% cream approximately 48 hours before performing skin tests, as antihistamine medicines can prevent or reduce positive reactions.

Do not apply Polaramin 1% cream to the eyes.
Do not apply the medicine to very large areas in the presence of abrasions to avoid absorption into the body. If absorbed, it may cause excitability, especially in children.
Do not apply to exuding surfaces (which present a fluid produced by inflammation), to open wounds, to areas of skin with blisters, to genitals and mucous membranes.
Do not cover the treated area with an occlusive bandage.
Exposure of the treated areas to the sun can lead to photosensitization phenomena (development of excessive reactivity of the skin to the sun).
In case of sensitization phenomena (allergy) stop treatment and consult your doctor.

Other medicines and Polaramin 1% cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
No medicines are known to alter the effect of Polaramin 1% cream.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before using this medicine.
If you are pregnant or during the breastfeeding period, use Polaramin 1% cream only if absolutely necessary and under the direct supervision of your doctor.

Driving and operating machinery
This medicine does not affect the ability to drive vehicles or operate machinery.

Polaramin 1% creamcontains cetyl alcohol and ethoxylated esters of lanolinwhich may cause local skin reactions (e.g. contact dermatitis).

Polaramin 1% creamcontains methyl parahydroxybenzoatewhich may cause local irritation.

Polaramin 1% creamcontains a fragrancewhich in turn contains limonene and linalool. Limonene and linalool can cause allergic reactions.

3. How to use Polaramin 1% cream

Use this medicine following exactly what is reported in this leaflet or the doctor's instructions
or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.
Apply Polaramin 1% cream to the affected area with gentle massage to promote its penetration in
depth, 2-3 times a day, depending on the intensity of the inflammatory symptom.
Caution: do not exceed the indicated doses without the doctor's advice. Use this medicine only for short
periods of treatment.
Stop using Polaramin 1% cream if you experience a burning sensation or inflammation of the
skin, or if the original condition persists or irritation develops.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in the
characteristics of the disorder.

If you use more Polaramin 1% cream than you should
No cases of overdose due to the use of this medicine are known.
In case of accidental ingestion/intake of Polaramin 1% cream, immediately inform your doctor or go to the
nearest hospital.

If you forget to use Polaramin 1% cream
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local application of Polaramin 1% cream may cause burning, inflammation and photosensitisation reactions of the
skin (for example, redness, blisters).
Following local application of antihistamines to extensive areas of the skin, adverse effects due to the passage of
the drug into the blood have been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-
avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Polaramin 1% cream

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Polaramin 1% cream contains

• The active ingredient is desloratadine maleate. 100 g of cream contains 1 g of desloratadine maleate.
• The other ingredients are: allantoin, glycerin, sorbitol 70%, glyceryl monostearate, spermaceti, cetyl alcohol, ethoxylated lanolin esters, methyl parahydroxybenzoate, liquid paraffin, natural lavender essence, purified water.

Description of the appearance of Polaramin 1% cream and contents of the pack
Polaramin 1% cream – tube of 25 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
BAYER S.p.A. – Viale Certosa, 130 – 20156 Milan

Manufacturer
Merck Sharp & Dohme B.V., Waarderweg 39 – 2031 BN - Haarlem (Netherlands)