Dimigal tablets a10

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.

Read this manual carefully, because it contains information that is important to you.
This medicine can be obtained without a prescription. However, it is necessary to use Dimigal carefully in order to achieve the best results with it.

Save the instructions. You may need to read it again.

If you have any further questions, ask your pharmacist.

If your symptoms worsen or you do not get better, you must contact your doctor.

If any side effect becomes serious or you notice any side effect that is not listed in this guide, please inform your doctor or pharmacist.

In this guide you will read:

1. What is Dimigal and what is it for?
2. What you need to know before taking Dimigal
3. How to take Dimigal
4. Possible side effects
5. How to store the medicine Dimigal
6. Package contents and other information

1. What is Dimigal and what is it for?

The drug Dimigal contains the active substance dimenhydrinate, which belongs to a group of drugs called antihistamines.

Dimigal is used in adults and children aged 2 years and older for:
- prevention of nausea, vomiting and/or dizziness in motion sickness (kinetosis);
- treatment of nausea and vomiting caused by Meniere's disease and other balance disorders.

2. What you need to know before taking Dimigal

Warn the doctor if you are taking other medicines, have a chronic disease, a metabolic disorder, are hypersensitive to medicines or have had allergic reactions to some of them.

You must not take Dimigal:

• if you are allergic (hypersensitive) to dimenhydrinate or to any of the auxiliary substances included in the composition of the medicine (see section 6).
• if you are hypersensitive to other antihistamines
• in the case of an acute asthma attack
• in case of glaucoma (increased eye pressure)
• if you have pheochromocytoma (tumor of the adrenal glands)
• in case of porphyria (metabolic disorder)
• if you have convulsions (in epilepsy and eclampsia)
• if you have an enlarged prostate.

Dimigal tablets should not be given to a child under 2 years of age.

Warnings and precautions

Before you start using this medicine, tell your doctor about any health problems you have or have had, as well as allergies.

Special caution is necessary in the following situations:

• in case of severe liver or kidney disease
• in chronic breathing problems and asthma
• in elderly patients who have problems with low blood pressure, dizziness, drowsiness, constipation, enlarged prostate
• Parkinson's disease (especially in the elderly)
• narrowing of the pylorus (part of the stomach at the transition to the small intestine)
• blockage of the pylorus and the beginning of the small intestine (duodenum)
• significant cardiac disorder (heart disease, circulatory disorders, heart rhythm disorders)
• the last trimester of pregnancy (see section Pregnancy and breast-feeding).

Alcohol should be avoided during the administration of Dimigal.

If any of the above situations apply to you, talk to your doctor before using Dimigal.
Dimigal tablets are used in children aged 2 years and older.

Other drugs and Dimigal

Please note that this information applies to medicines you have recently used or are still using, as well as medicines you will take in the future. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, vitamins, herbal medicines, homeopathic medicines or medicines prescribed by other doctors.

Before you start taking Dimigal, you need to tell your doctor if you are taking any of the following medicines:

• drugs with anticholinergic effect (atropine, some drugs against Parkinson's disease, tricyclic antidepressants, MAO inhibitors);
• depressants of the CNS system (benzodiazepines, barbiturates, opioid analgesics, hypnotics, sedative antipsychotics, baclofen, thalidomide...) because simultaneous use can lead to an increased effect of these drugs;
• ototoxic drugs, i.e. medicines that damage hearing (antibiotics from the group of aminoglycosides)
• drugs that affect the ECG (e.g. some antiarrhythmics, antibiotics, antimalarials, antihistamines) or drugs that lead to a decreased concentration of potassium in the blood, such as some diuretics (medicines to expel fluid); simultaneous use with Dimigal should be avoided
• antihypertensives (medicines to lower high blood pressure) because increased fatigue and an excessive drop in blood pressure may occur
• adrenaline, noradrenaline and other drugs of similar action.

Alcohol increases the sedative effect of this medicine.
Impairment of alertness and attention may affect the ability to drive and use machines.

Lab analysis
It is necessary to stop taking Dimigal tablets a few days before testing for allergens, since it can lead to false negative results in allergy tests.

With long-term use, it can show false positive elevated levels of theophylline in the serum.

Use of Dimigal with alcohol

While taking the medicine, do not drink alcohol or take medicines that contain alcohol, because this can cause an increase in the sedative effect (drowsiness). The ability to drive and use machines may be reduced.

Pregnancy, breastfeeding and fertility

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

Pregnancy
After the sixth month of pregnancy, the drug Dimigal must not be used because it can cause premature birth.
It is not recommended to use the drug during pregnancy unless it is necessary, which will be assessed by your doctor.

Breastfeeding
The drug Dimigal is excreted in milk, so it is necessary to assess the importance of using the drug in nursing mothers.
Administration of this medicine may reduce milk production in nursing mothers. If signs of restlessness and irritability appear in the infant, your doctor will decide whether to stop breastfeeding or use the medicine.

Driving vehicles and operating machines

Dimigal can cause drowsiness, dizziness, blurred vision and impaired coordination. The medicine must not be taken by people who drive a motor vehicle or operate machinery.

The medicine Dimigal tablets contains lactose, monohydrate and color Tartrazine Lake

In case of intolerance to certain sugars, consult your doctor before using this medicine, as it contains lactose. The medicine Dimigal can cause allergic reactions, because it contains the color Tartrazine Lake (E102).

3. How to take Dimigal

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

Dimigal is administered orally.

To prevent nausea, vomiting and/or dizziness in motion sickness (motion sickness), Dimigal should be taken 30 minutes before departure.

Swallow the tablet with enough liquid (eg water), preferably after a meal.

The tablet can be divided into four equal doses.

Children aged 2-6 years
12.5-25 mg (¼ – ½ tablet) every 6-8 hours as needed, no more than 1.5 (one and a half) tablets (75 mg) in 24 hours.

Children aged 6-14
25 – 50 mg (½-1 tablet) every 6-8 hours as needed, no more than 3 tablets (150 mg) in 24 hours.
Dimigal should not be used in children under 5 years of age.

Adults and children over 14 years old
50 – 100 mg (1-2 tablets) every 4-6 hours as needed, no more than 8 tablets (400 mg) in 24 hours.

In elderly people, the drug should be used in the lowest recommended dose for adults.

If you have taken more Dimigal than you should

In case of overdose or accidental ingestion of an excessive amount of medicine, contact your doctor or the nearest health facility immediately. If possible, take the medicine box or this leaflet with you so that the doctor knows what medicine you have taken.

Symptoms of overdose are: dryness of the mouth, nose and throat, redness of the face, slowed or difficult breathing, a feeling of weakness and in more severe cases dilation of the pupils, excitement, i.e. excessive excitement, hallucinations, confusion, ie. confusion, ataxia ie. gait disturbance, occasional clonic convulsions, i.e. cramps. Coma, cardiac arrest and death can also occur. Signs of overdose can appear up to two hours after the administration of an overdose of the drug.

If you forget to take your medicine

Dimigal Never take a double dose of the medicine to make up for forgetting to take the medicine!
If you forget to take the medicine, continue taking it when you remember and then continue using it according to the usual schedule. However, if you have a few hours left until the next administration, do not take the missed dose, but wait for the next administration.

If you suddenly stop taking the medicine

Dimigal There is no data on the occurrence of adverse reactions if you suddenly stop taking the drug Dimigal.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Immediately stop taking the medicine and seek medical help in case of an allergic reaction:

• anaphylactic shock
• swelling of the face and neck that can make breathing difficult
• rash, redness

Adverse reactions are listed by frequency:

Very common (may affect more than 1 in 10 patients taking the medicine)
- muscle weakness

Common (may occur in up to 1 in 10 patients taking the medicine)
- drowsiness
- mood swings, anxiety, anxiety
- dry mouth, constipation, diarrhea, nausea, stomach pain
- clogged nose
- urination disorder (due to urine retention)

Uncommon (may affect up to 1 in 100 patients taking the medicine)
- balance disorder, impaired concentration and memory (more common in the elderly), involuntary tremors, lack of coordination, distraction, hallucinations
- insomnia Rare (may occur in up to 1 in 1000 patients taking the drug)
– headache, sleep disorder, dizziness
- palpitations, rapid heartbeat, drop in blood pressure (especially when standing up)
- increased eye pressure, visual disturbances such as dilated pupils, blurred vision, double images
- buzzing in my ears
– rash, redness
- islands
- anaphylactic shock (severe allergic reaction with a possible fatal outcome)

Very rare (may occur in up to 1 in 10,000 patients taking the medicine)
- paradoxical CNS stimulation (insomnia, restlessness, nervousness), especially in children
- blood disorder (hemolytic anemia, reduced number of white blood cells, reduced number of platelets, i.e. blood platelets)

Unknown (cannot be estimated from available data)
- loss of appetite
- allergic skin reactions, photosensitivity
- liver function disorder (jaundice)

Decreased secretion of milk, vomiting, increased density of bronchial mucus and convulsions may also occur.

Reporting adverse reactions

If you experience any unwanted reaction, you should inform your doctor or pharmacist. This includes any possible side effects that are not listed in this guide. By reporting side effects, you can help evaluate the safety of this medicine. You can report suspected adverse reactions to the Agency for Medicines and Medical Devices of Serbia (ALIMS):

Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs

5. How to store the medicine Dimigal

Keep out of the reach and sight of children.

You must not use the medicine Dimigal after the expiration date indicated on the outer packaging ("Expiry Until").
The term of use expires on the last day of the specified month.

Store in the original packaging, in order to protect from light and moisture.

Unusable medicines are handed over to the pharmacy, which has a notice that the pharmacy collects unusable medicines from citizens. Unusable medicines must not be thrown into the sewer or together with municipal waste. These measures will help protect the environment.

6. Contents of the package and other information

What Dimigal contains

Active substance content:

1 tablet contains 50 mg of dimenhydrinate.

Content of auxiliary substances: lactose, monohydrate; starch, corn; starch, pregelatinized; color Tartrazine Lake (E102); magnesium stearate.

What the medicine Dimigal looks like and the contents of the package

Tablet

Round, flat tablets, yellow in color with a cross score line on one side. The tablet can be divided into equal doses.

Packaging:
The finished product is packed in an inner package, which is a blister of ALU/PVC tape and PVC/PVdC tape with 10 tablets.
The outer packaging is a collapsible cardboard box containing one blister and the instructions for the medicine.

License holder and manufacturer

Galenika ad Belgrade
Batajnički drum bb, Belgrade, Republic of Serbia

Mode of administration of the drug:

The medicine can be dispensed without a doctor's prescription.

License number and date:
515-01-04019-16-001 from 06/05/2017

Before use, study the instructions in detail. Consult your doctor or pharmacist about indications, precautions and adverse drug reactions.