20 mg capsule, hard 
alimemazine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet you will find information about: 
1. What Alimemazin Evolan is and what it is used for 
2. What you need to know before you take Alimemazin Evolan 
3. How to take Alimemazin Evolan 
4. Possible side effects 
5. How to store Alimemazin Evolan 
6. Contents of the packaging and other information 

1. What Alimemazin Evolan is and what it is used for

Alimemazin Evolan has sedative and sleep-inducing properties.

Alimemazine Evolan is used

-in case of anxiety and sleep disorders in adults. 

-as sedatives before anesthesia in adults and children over 12 years.

-in case of anxiety and other symptoms due to alcohol abuse or drug addiction in adults.

Alimemazine contained in Alimemazine Evolan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you take Alimemazin Evolan

Do not take Alimemazin Evolan

  • if you are allergic to alimemazine or any of the other ingredients of this medicine (listed in section 6).
  • Alimemazine Evolan should not be used in case of a concomitant overdose of alcohol or sedatives.
  • People who have leukopenia or have previously had agranulocytosis (blood changes), as well as those who have morbid muscle weakness ( myasthenia gravis ), should not be treated with Alimemazine Evolan.
  • Alimemazine Evolan capsules should not be given to children, see section 2.

Warnings and cautions

Talk to your doctor or pharmacist before taking Alimemazine Evolan.

If you have any of the following conditions, you should consult your doctor before starting treatment with Alimemazine Evolan: Liver or kidney damage. Convulsive disorders (eg epilepsy ).

In elderly patients with dementia, there may be an increased risk of cerebral hemorrhage ( stroke ).

Caution in case of pronounced slow heart rhythm ( bradycardia ), cardiovascular disease, and an inherited form of ECG change (prolonged QT time ).

Contact a doctor immediately if you suffer from a condition called a malignant neuroleptic syndrome, which causes a combination of e.g. fever, muscle stiffness, disturbance of consciousness, and variations in blood pressure. You may need immediate medical attention.

If you are being treated for diseases other than those prescribed by Alimemazine Evolan, you should tell your doctor.

Rising age generally leads to an increased sensitivity to drugs. Alimemazine Evolan should therefore be used with caution in elderly patients, as they may be more sensitive to the effects of alimemazine such as muscle effects, anxiety, restlessness, dizziness, fatigue, drop in blood pressure, inability to empty the bladder, and constipation.

Children and young people

Alimemazine Evolan should not be given to children under 2 years of age due to the risk of pronounced fatigue and impaired breathing.

Alimemazine Evolan capsules should not be given to children 2-12 years of age, at these ages alimemazine is recommended in the form of drops, solution.

Other medicines and Alimemazin Evolan

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

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If certain other medicines are taken at the same time, the treatment effect may be affected and the dose of one of Alimemazine Evolan or of the other medicine may need to be changed or other precautions may need to be taken.

It is especially important that you tell your doctor if you are taking any of the following medicines:

  • certain neuroleptics (remedies for mental illness)
  • certain remedies for irregular heartbeat (eg quinidine )
  • erythromycin, moxifloxacin ( antibiotics )
  • methadone (a drug used to treat addiction)
  • mefloquine (malaria medicine)
  • certain antidepressants (tricyclics)
  • levodopa (a drug used to treat Parkinson’s disease )
  • lithium (a drug used to treat manic conditions and depression)
  • cisapride (anti-gastrointestinal disorders)
  • certain diuretic agents

Alimemazin Evolan with alcohol

Do not drink alcohol or take any medicines containing alcohol while taking alimemazine tablets. This is because alcohol can increase the risk of you getting side effects. It can also cause severe breathing difficulties.

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine. There is a risk that the fetus is affected. Therefore, always consult a doctor before using Alimemazine Evolan during pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine. Alimemazin Evolan passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if you are taking Alimemazine Evolan more than temporarily while breast-feeding.

Driving and using machines

During treatment with Alimemazine Evolan, the reactivity may be reduced. This should be taken into account when sharper attention is required, eg when driving a car.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or 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.

Alimemazine Evolan contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Alimemazine Evolan.

How to take Alimemazin Evolan

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is

In the treatment of anxiety disorders and other symptoms due to alcohol abuse or drug addiction in adults: At the beginning of treatment 40-60 mg 2-3 times daily, which after a few days of treatment can usually be reduced to 5-10 mg 2-3 times daily.

Because Alimemazine Evolan capsules do not allow for a lower dose, other alimemazine-containing medicines should be chosen.

Sleep disorders in adults: 10-30 mg 1-2 hours before bedtime. At doses other than 20 mg, other alimemazine-containing medicines should be chosen.

Use for children and adolescents

Alimemazine should not be given to children under 2 years of age.

For children 2-12 years, alimemazine is recommended in the form of drops, solution.

If you forget to use Alimemazin Evolan

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

4. Possible side effects

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

The side effects vary depending on the dose, duration of treatment, and the disease being treated. Many of the side effects that can occur only at the beginning of treatment and usually disappear on their own after some time of continued treatment.

Stop taking Alimemazin Evolan and contact a doctor immediately or visit the nearest emergency room if you experience the following symptoms:

  • fever with muscle stiffness and nausea, a rare side effect that may affect less than 1 in 1,000 people
  • very fast, uneven, or strong heart rhythm (palpitations). You may also experience difficulty breathing such as wheezing, shortness of breath, tightness in the chest, and chest pain, a rare side effect that may affect less than 1 in 1,000 people.
  • in rare cases, Alimemazine Evolan may affect the white blood cells so that the immune system is adversely affected. If you develop an infection with symptoms such as fever in combination with a severe deterioration in general health or fever with local infectious symptoms such as sore throat/mouth or difficulty urinating, you should contact a doctor immediately so that blood samples can be taken to rule out white blood cell deficiency. ( agranulocytosis ). It is important that you inform healthcare professionals about your medication in connection with this.

Common (more than 1 in 100): Fatigue, especially at the beginning of treatment. Temporary headache. Nasal congestion. Slight dizziness. Dry mouth can occur. With long-term treatment, increases the risk of tooth and oral mucosal damage. You should therefore take care of your toothbrushing and other oral hygiene extras carefully during treatment with Alimemazin Evolan.

Uncommon (less than 1 in 100): Sluggish stomach. Difficulty throwing water may occur (especially in older men). Temporary deterioration of visual acuity may occur.

Rare (less than 1 in 1000): Especially at higher doses slight tremors, stiffness, twitching or shaking in eg hands and fingers. With long-term treatment, they can turn into twitches in the face, grimacing, and strange tongue movements. In some cases, a special form of internal anxiety occurs, which manifests itself in difficulty sitting still. Drops in blood pressure with dizziness may occur. Jaundice without liver damage. High dose and long-term treatment can cause clouding of the lens and cornea of the eye.

Seizures have been reported. 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alimemazin Evolan

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 label and carton after EXP. The expiration date is the last day of the specified month.

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

6. Contents of the packaging and other information

Content declaration

  • The active substance is alimemazine (as alimemazine hemitartrate) 
  • The other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), gelatin.

What the medicine looks like and the contents of the pack

White cylindrical gelatin capsule, length 14.3 ± 0.3 mm.

White plastic jar with 100 capsules

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Evolan Pharma AB

Box 120

182 12 Danderyd

Manufacturer

Balkanpharma-Razgrad AD

April 6, June Blvd.

7200 Razgrad, Bulgaria

Muhammad Nadeem

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