Dimex should not be used in the following cases:

• Hypersensitivity to the medicinal or excipients;
• Acute asthma attacks;
• Increased intraocular pressure;
• Enlargement of the prostate gland;
• Moaning of the ureter;
• Stenotic peptic ulcer;
• Severe kidney and liver disorders;
• Metabolic alkalosis;
• Pregnancy and lactation;
• Children under 5 years of age.

Precautions and warnings

In young children, strict dosing is required. In case of overdose and in sensitive individuals, antihistamines can cause agitation, hallucinations, seizures. Use with caution in elderly patients. May cause dizziness, drowsiness, hypotension. It should be used with caution in patients with bronchial asthma due to difficulty in secretion.

Pregnancy and breast-feeding

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

Dimex is not used during pregnancy and lactation.

Effects on ability to drive and use machines:

Dimex may cause drowsiness and  incoordination, therefore it should be used with caution by drivers of vehicles and machine operators.

Interactions 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. Co-administration of Dimex with MAO inhibitors (medicines used to treat depression) may increase its effects. Dimex enhances the effect of alcohol and other drugs that suppress the central nervous system (hypnotics, sedatives) when administered simultaneously.

Unwanted reactions:

Like all medicines, Dimex can have side effects. However, they are not necessarily seen in all patients, so you may not get any reaction. During the treatment with the syrup it is possible to observe: general weakness, fatigue, decreased attention, dizziness, drowsiness, headache, incoordination, anxiety, increased agitation (especially in children), irritability, insomnia, lowering of blood pressure, disorders of heart rhythm, dry nose, mouth and throat, nasal congestion, difficulty breathing, nausea, vomiting, constipation, diarrhea, difficulty urinating or holding urine, itching, rash, photoallergic reactions, transient visual disturbances, tinnitus. If you get side effects, including those not mentioned in this leaflet, tell your doctor.

DIMEX syrup 125 ml SOPHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

DIMEX 9.96 mg/5 ml + 99.6 mg/5 ml syrup
DIMEX 9.96 mg/5 ml + 99.6 mg/5 ml syrup
diphenhydramine hydrochloride / ammonium chloride

Read all of this leaflet carefully as it contains important information for you.

• This medicine can only be obtained without a doctor’s prescription. However, in order to get the best treatment results, you should carefully follow the instructions for use of the medicinal product.
• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• You should seek medical attention if your symptoms worsen or do not improve after a few days.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Dimex is and what it is used for
2. Before taking Dimex
3. How to take Dimex
4. Possible side effects
5. How to store Dimex
6. Further information

1. WHAT DIMEX IS AND WHAT IT IS USED FOR

Dimex syrup is a combined medicinal product with a pronounced antitussive effect. It is used to relieve irritating and spastic cough in inflammatory diseases of the respiratory tract.

2. BEFORE TAKING DIMEX

This medicine may not be suitable for some patients. Carefully read section 2 “Before taking Dimex” and if you have any doubts about its use, consult a doctor or pharmacist.

Do not take Dimex:

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Dimex;
• in acute asthma attacks;
• with increased intraocular pressure;
• if you have an enlarged prostate;
• if you have narrowing of the urethra;
• with stenosing peptic ulcer (causes narrowing of the exit of the stomach);
• in severe renal and hepatic disorders;
• metabolic alkalosis (occurs with loss of chlorides).

Do not use this medicine if you are pregnant or breast-feeding!
Do not use the drug to children under 6 years of age!

Take special care when using Dimex:

• if you have bronchial asthma;
• if you are over 65 years old. In adult patients, the drug may cause dizziness, drowsiness, arterial hypotension (low blood pressure);
• observe exactly the dosage in young children;
• Do not exceed the dose indicated in this leaflet, because in sensitive individuals and children, antihistamine (antiallergic) products may cause agitation, hallucinations, seizures.

Taking other medicines

Please consult your pharmacist if you are taking or have recently taken:

• medicines to treat depression;
• sleeping pills;
• tension-relieving drugs, soothing;
• drugs for the treatment of cardiovascular diseases (metoprolol);
• Atropine.

Reception of Dimex with food and beverages

No alcohol should be consumed during treatment with the product.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Dimex if you are pregnant or breast-feeding.

Driving and using machines

Dimex syrup can cause drowsiness and impaired coordination. If you experience such symptoms, do not drive or engage in activities that require caution until they subside.

Important information about some of the ingredients of Dimex

This medicinal product contains 7.68 % vol.ethanol (alcohol), i.e. 312 mg (0.384 ml) in 5 ml syrup, equivalent to 7.8 ml beer or 3.2 ml wine. Harmful to those suffering from alcoholism. To be taken into account in pregnant and nursing mothers, children and high-risk groups, such as patients with liver disease or epilepsy.
Dimex syrup contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. HOW TO TAKE DIMEX

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

The syrup is taken by mouth. The usual dose is:

• Adults and children over 14 years: 5-10 ml 3-4 times a day;
• Children from 9 to 14 years: 5 ml 3-4 times a day;
• Children from 6 to 8 years: 2.5 to 5 ml 3-4 times a day.

The syrup is not recommended for children under 6 years!

If you take more Dimex than you should

If you take a dose greater than prescribed, you may experience dizziness, drowsiness, impaired coordination, restlessness, irritability, hallucinations and seizures, redness of the skin, gastrointestinal disorders.
Administration of high doses can cause cardiovascular collapse or coma.
If you take a dose greater than prescribed, contact your doctor or nearest medical institution.

If you forget to take Dimex

If you forget to take 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. Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dimex can cause side effects, although not everybody gets them.
Stop using the medicine and contact a doctor or medical facility immediately if you experience or notice allergic reactions, such as rashes on the skin, itching, hives (hives), swelling of the face, lips, throat and tongue.
If you experience heart rhythm disturbances, difficulty urinating or urinary retention, and in young children or elderly patients notice increased excitability and irritability, discontinue taking the drug and consult a doctor. Dimex syrup may cause, albeit rarely, other side effects – general weakness, fatigue, decreased attention, dizziness, drowsiness, headache, coordination disturbance or difficulty moving, tremor, muscle twitching, tingling of the skin, convulsions, restlessness, insomnia, lowering blood pressure, dry nose, mouth and throat, nasal congestion, laboured breathing, nausea, vomiting, constipation, diarrhoea, transient visual disturbances, tinnitus, increased sensitivity to light.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE DIMEX

Store in the original package at a temperature below 25°C. Keep out of the reach of children.

Shelf life after opening the bottle: 1 month.

Do not use Dimex syrup after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION

What Dimex contains

• The active substances are: diphenhydramine hydrochloride and ammonium chloride. 5 ml of syrup contains 9.96 mg of diphenhydramine hydrochloride and 99.6 mg of ammonium chloride.
• The other ingredients are: ethanol 96%, sucrose, benzoic acid, sorbic acid, levomenthol, sodium citrate 2H20, citric acid monohydrate, glycerol, liquid essence “Raspberry”, purified water.

What Dimex looks like and contents of the pack

Dimex is a pale-yellow to yellow-brown solution with a sweet taste and a specific raspberry smell.
125 ml syrup in a dark brown glass bottle type “Pilferpruf” with aluminum or polyethylene screw cap with ALKOzell type “Pilferpruf” seals or in dark brown PET bottle type “Pilferpruf” with polyethylene screw cap with ALKOzell type “Pilferpruf” gaskets.
1 bottle in a cardboard box, along with a measuring cup and a leaflet.

Marketing authorisation holder and manufacturer:

SOPHARMA AD, Bulgaria.