What is Prometazin Actavis 25mg Used For, Side Effects

prometazin actavis contains promethazine hydrochloride, which is part of a group of medicines called phenothiazines. It blocks the effect of histamine, a substance that is found in the body’s tissues and which, among other things, triggers itching in allergic reactions. Like many histamine-blocking substances, it also has a calming effect.

Prometazin actavis can be used in the following situations:

Sleep disorders
Severe anxiety
As a sedative before surgery or dental procedures
Motion sickness (for example, seasickness)
Itchy skin and allergies
Nausea and dizziness
As an aid in the treatment of alcohol and drug abuse

Prometazine contained in Prometazine Actavis may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or healthcare professional for further questions, and always follow their instructions.

What You Need Yo Know Before You Take Prometazin Actavis?

Do Not Take Prometazin Actavis:

If you are allergic to prometazine hydrochloride or any of the other ingredients of prometazin actavis (listed in section 6).
If you are taking an antidepressant that belongs to a group of medicines called monoamine oxidase inhibitors ( MAOIs ). You should also not take Prometazine Actavis if you have stopped taking one of these MAOIs within the last 14 days. If unsure, talk to your doctor or pharmacist (see ‘Other medicines and Prometazine Actavis’).

Prometazine Actavis should not be given to children under 5 years of age.

Warnings And Cautions:

Talk to your doctor or pharmacist before taking Prometazine Actavis. This is especially important if you:

Have severe dizziness, drowsiness, or headache
Has enlarged prostate
Have narrowing of the lower stomach or have difficulty urinating
Suffers from severe muscle weakness ( myasthenia gravis )
Have liver problems
Have a risk of cerebral hemorrhage ( stroke )
Have changes in heart rate

Due to dry mouth (a common side effect), tooth and oral mucosal damage are at risk, especially with prolonged use. Therefore, you should brush your teeth thoroughly with fluoride toothpaste twice daily when taking prometazin actavis.

Treatment with Prometazine Actavis can cause contact lens wearer problems due to reduced tear flow.

Prometazine Actavis can affect the results of pregnancy tests taken with urine samples, which may give false-positive or false-negative results.

Talk to your doctor or pharmacist before taking Prometazine Actavis if you are unsure if any of the above applies to you.

Other Medicines And Prometazine Actavis:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.

Do not take prometazin actavis, and tell your doctor or pharmacist if you are taking or have taken the following in the last 2 weeks:

Some antidepressants are called monoamine oxidase inhibitors ( MAOIs ). If you are not sure, talk to your doctor or pharmacist.

It is also very important to tell your doctor or pharmacist if you are taking medicines for:

Irritable bowel syndrome, asthma, and overactive bladder (anticholinergic drugs), as these may increase the risk of:
- Dizziness
- Dry mouth
- Blurred vision
Arrhythmias of the heart and other heart diseases e.g.
- Flecainide
- Amiodarone
- Quinidine
- Beta-blockers
Treatment of bacterial infections e.g.
- Certain antibiotics, such as moxifloxacin
- Erythromycin
Treatment of fungal infections such as:
- Terbinafine
Pain condition or drug dependence, e.g.:
- Methadone
Malaria drug
- Mefloquine
Intestinal disease, e.g.,
- Cisapride
Mental disorders, e.g.,
- Lithium and neuroleptics such as:
  - Haloperidol
  - Clozapine
  - Risperidone
Depression e.g.
- VTricyclic antidepressants
- Selective serotonin reuptake inhibitors ( SSRIs ) such as:
  - Paroxetine
  - Fluoxetine
Anxiety, e.g.,
- Diazepam
Sleep problems e.g.
- Zolpidem

Avoid concomitant treatment with certain diuretics (thiazide diuretics), as these may reduce the potassium level in the blood and thus increase the risk of arrhythmias in the heart.

prometazin Actavis With Food, Drink, And Alcohol:

Do not drink alcohol while taking Prometazine Actavis.

Pregnancy And Breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking prometazin actavis.

Driving And Using Machines:

During treatment with Prometazine Actavis, the ability to react may be reduced. This should be considered when sharper attention is required, e.g., driving a car. These effects may persist the following morning. Make sure you are not affected before driving or using machines.

You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects.

Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Prometazine Actavis Contains Sodium:

prometazin actavis contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free.’

How To Take prometazin Actavis?

Always take prometazin actavis exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
The recommended dose is:
- Sleep disorders:
  - Adults: 25-50 mg at night.
  - Children 5-12 years: 25 mg at night.
  - Sometimes the medication is interrupted every three or four nights.
- Severe anxiety and hyperactivity:
  - Adults: 25-50 mg, up to 400-500 mg daily.
- Before an operation or a dental procedure:
  - Adults: 25-50 mg one hour before treatment, possibly the same dose the night before.
  - Children 6-12 years: 25 mg one hour before treatment, possibly the same dose the night before.
- Motion sickness:
  - Adults: 25 mg 1-2 hours before the trip or the evening before. If necessary, two more doses can be taken in one day.
- Allergic conditions:
  - Adults: 25-50 mg at night.

If You Take More Prometazin Actaviss Than You Should:

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Bring the medicine pack so the doctor can identify what you have taken.

If You Forget To Take Prometazin Actavis?

Do not take a double dose to make up for a forgotten tablet.

Ask your doctor or pharmacist if you have any further questions about using this product.

Possible Prometazin Actavis Side Effects:

This medicine can cause side effects like all medicines, although not everybody gets them.

Stop taking Prometazine Actavis and contact your doctor or hospital directly if you notice any of the following side effects:

Liver problems can cause eyes and skin to turn yellow (jaundice).
Jerky movements and problems such as slow movements, muscle stiffness, tremors, and restlessness.
Very fast or uneven heart rhythm or chest pain.

Other possible side effects:

Common (may affect up to 1 in 10 users):

Dry mouth
Drowsiness. When Prometazine Actavis is taken at night, you may feel drowsy the next morning. This disappears after a few days of treatment

Uncommon (may affect up to 1 in 100 people):

Dry eyes
Difficulties for the eye to switch between near and far vision
Constipation
Difficulty urinating

How To Store Prometazine Actavis?

Keep this medicine out of sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Contents Of The Pack And Other Information:

Content Declaration

The active substance is promethazine hydrochloride.
Other ingredients are Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycolate, stearic acid, and magnesium stearate. Tablet cover: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), talc.

What The Medicine Looks Like And The Contents Of The Pack?

Prometazine Actavis 25 mg film-coated tablets are white, oval, 9.8 x 6.2 mm biconvex, marked with “C25” on one side and smooth on the other, in blister packs.
Pack sizes
- Blister:
- 2, 4, 8, 12,16, 30, 50, 100 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder And Manufacturer

Actavis Group PTC EHF.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Actavis UK Limited

Whiddon Valley, Barnstaple

North Devon EX32 8NS

Teva Operations Poland Sp. z oo

ul. Mogilska 80

31-546, Kraków

Poland

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