Dimelan

Package leaflet: Information for the patient

Dimelan, 1 mg/ml, oral drops, solution
Dimetindene maleate
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

1. What Dimelan is and what it is used for
2. Important information before taking Dimelan
3. How to use Dimelan
4. Possible side effects
5. How to store Dimelan
6. Contents of the pack and other information

1. What Dimelan is and what it is used for

Dimelan contains the active substance dimetindene maleate. It belongs to a group of medicines called antihistamines. It works by blocking the effects of histamine, a substance released by the body during allergic reactions. Dimelan relieves itching and skin irritation due to skin rashes, reduces swelling, and alleviates symptoms of allergic rhinitis such as runny nose, sneezing, nasal itching, and eye itching and watering.

Dimelan is used to treat symptoms of allergic conditions:

• of the skin: urticaria, itching of various origins, endogenous eczema, provided that a doctor has previously diagnosed these conditions in the patient;
• of the respiratory system: seasonal allergic rhinitis (hay fever) and perennial rhinitis (e.g. allergy to house dust, animal fur, feathers), provided that a doctor has previously diagnosed these conditions in the patient. Dimelan also relieves itching associated with infectious diseases (e.g. chickenpox), if a doctor has previously diagnosed such conditions in the patient, or following insect bites or stings.

Dimelan is indicated for use in adults, adolescents and children from the age of 1 year and older. Dimelan is indicated for allergic rhinitis in adults, adolescents and children aged 6 years and older.

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Dimelan

When not to use Dimelan:
if the patient is allergic to dimethindene maleate or any of the other ingredients of this
medication (listed in section 6).
Dimelan should not be administered to infants under 1 year of age.

Warnings and precautions
Before starting to use Dimelan, consult a doctor or pharmacist if the patient has:

• glaucoma,
• urinary retention (e.g. caused by benign prostatic hyperplasia),
• epilepsy.

Elderly patients should consult a doctor before using this medication, as they are more likely to experience adverse effects such as increased heart rate, dry mouth, blurred vision, constipation, agitation, or fatigue. Elderly patients should exercise caution when taking Dimelan. Dimelan should not be used in elderly patients who show signs of disorientation.

Children and adolescents
Do not use Dimelan in children under 1 year of age.
Antihistamines have been observed to cause excitability (increased nervousness) in younger children. Consult a doctor regarding use of Dimelan in children under 12 years of age.

Interaction of Dimelan with other medications
Inform your doctor or pharmacist about all medications currently used or recently used, as well as any medications you plan to take.
Unless otherwise directed by a physician, do not use Dimelan if the patient is taking any of the following medications:

• antidepressants,
• anticholinergic drugs, e.g. bronchodilators (medications used in the treatment of asthma and bronchospasm, i.e. narrowing of the airways), medications used for spastic conditions in the abdominal cavity (stomach or abdominal cramps), mydriatic agents (drugs that dilate the pupils), medications used to treat urinary incontinence or overactive bladder. Concomitant use of tricyclic antidepressants or anticholinergic drugs may increase the risk of worsening glaucoma or urinary retention.
• sedatives, anxiolytics, or hypnotics,
• anticonvulsants (medications used in the treatment of epilepsy),
• opioid analgesics,
• antihistamines (medications used to treat various allergy symptoms),
• antiemetics,
• procarbazine (a medication used in cancer treatment),
• scopolamine (a medication used to prevent motion sickness),
• antipsychotics (medications used in the treatment of psychiatric disorders),
• alcohol.

Dimelan with food, drink, and alcohol
Like many other antihistamines, Dimelan may enhance the effects of alcohol.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medication.
If the patient is pregnant, Dimelan should be used only on medical advice.
Use of Dimelan during breastfeeding is not recommended.

Driving and operating machinery
Like other antihistamines, Dimelan may cause fatigue, reduced concentration, and slowed reaction times in some individuals. This is particularly true when used with alcohol. In such cases, patients should avoid driving, operating machinery, or performing any activities requiring heightened concentration.

Dimelan contains propylene glycol E 1520, sodium, and benzoic acid E 210

• This medication contains 200 mg of propylene glycol in a single dose (40 drops), equivalent to 100 mg/ml.
• This medication contains less than 1 mmol (23 mg) of sodium per dose (40 drops), meaning the medication is considered "sodium-free".
• This medication contains 2 mg of benzoic acid in a single dose (40 drops), equivalent to 1 mg/ml.

3. How to use Dimelan

This medicine should always be used exactly as described in this patient leaflet, or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Do not exceed the recommended dose.
If there is no improvement after 3 days, or if the patient feels worse, consult a physician.
Dimelan should not be used for longer than 14 days without consulting a physician.
Adults and adolescents over 12 years of age
20 to 40 drops three times daily.
The recommended dose for patients prone to drowsiness is 40 drops at night and 20 drops in the morning.
Children
Children aged 1 to 12 years
The recommended daily dose is 2 drops per kg of body weight per day, divided into 3 doses (e.g. 8 drops
three times daily for a 2-year-old child weighing 12 kg). Detailed information can be found in the dosing table below.

Elderly patients (over 65 years of age)
The same dose as for adults may be used.
How to use Dimelan
To dispense the drops, hold the bottle with dropper vertically upside down.
If difficulties occur when dropping, tap the bottom of the bottle several times with a finger.
The drops should be taken undiluted (e.g. on a teaspoon). Dimelan drops should not be exposed to high temperatures. If the child is fed with a spoon, administer the Dimelan drops undiluted on a small teaspoon.
Use of a higher than recommended dose of Dimelan
In case of overdose or accidental ingestion of the medicine by a child, contact a doctor immediately.
Missed dose of Dimelan
If a dose of Dimelan is missed, it should be taken as soon as possible, unless less than 2 hours remain before the next dose. Then continue treatment according to the recommended dosing schedule. Do not use a double dose to make up for a missed dose.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everybody will experience them.
If any of the following symptoms occur, which may indicate an allergic reaction, STOP USING
Dimelan and seek immediate medical help.

• Shortness of breath or difficulty swallowing.
• Swelling of the face, lips, tongue or throat.
• Severe itching of the skin with red rash or pimples, muscle cramps. These adverse effects are very rare (may occur in fewer than 1 in 10,000 people).

Other adverse effects that may occur are usually mild and temporary.
Adverse effects are more common at the beginning of treatment.
Very common (may occur in more than 1 in 10 people):

• Fatigue.

Common (may occur in fewer than 1 in 10 people):

• Drowsiness, nervousness.

Rare (may occur in fewer than 1 in 1,000 people):

• Anxiety.
• Headache, dizziness.
• Indigestion, nausea, dry mouth and throat.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dimelan

Keep the medicine out of sight and reach of children.
Store below 25°C. Keep the bottle in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
The shelf life after first opening the immediate container is 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Dimelan contains
The active substance is dimethindene maleate. 1 ml of Dimelan drops contains 1 mg of
dimethindene maleate.

• Other ingredients are: propylene glycol (E 1520), disodium phosphate dodecahydrate, citric acid monohydrate, benzoic acid (E 210), disodium edetate, sodium saccharin (E 954), purified water.

What Dimelan looks like and contents of the pack
Dimelan oral drops, solution is a clear, colourless and odourless solution.
Dimelan oral drops are packed in a 20 ml amber glass type III bottle with a dropper made of LDPE, with a PP screw cap and an LDPE protective cap with child-resistant closure, placed in a cardboard box.
Pack sizes: 20 ml, 50 ml, 3×20 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer
Mipharm S.P.A.
Via Bernardo Quaranta 12
20141 Milan, Italy
This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Dimelan
Czech Republic: Dimalen
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonińskiego 3
00-728 Warsaw, Poland
Tel: +48 22 35 12 500
Email: [email protected]