40 mg / ml oral drops, alimemazine solution

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

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

– If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

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

Alimemazine Orifarm contains alimemazine which belongs to a group of medicines called phenothiazine derivatives which have sedative and sleep-inducing properties. Alimemazin Orifarm counteracts nausea and vomiting. Alimemazin Orifarm relieves allergies and also has antipruritic properties. Alimemazin Orifarm is used for:


Adults

  • anxiety and other symptoms due to alcohol or drug abuse
  • sedatives before anesthesia
  • itching and allergies s
  • sleep disorders


Children over 2 years

  • vomiting
  • behavioral disorders and anxiety disorders
  • sedatives before anesthesia
  • itching and allergies s
  • sleep disorders


Alimemazine contained in Alimemazine Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. 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 using Alimemazin Orifarm

Do not use Alimemazin Orifarm

  • if you are allergic to alimemazine or any of the other ingredients of this medicine (listed in section 6).
  • in case of concomitant overdose of alcohol, opiates or sedatives.
  • if you have leukopenia or have previously had agranulocytosis (blood changes).
  • if you have morbid muscle weakness ( myasthenia gravis ).
  • for children under 2 years.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Alimemazin Orifarm if you:

  • have liver or kidney damage.
  • suffers from spasticity (a condition with increased muscle tension) (eg parkinsonism ).
  • have seizures (eg epilepsy ).
  • is older with dementia, there may be an increased risk of cerebral hemorrhage ( stroke ).
  • has 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 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.


Alimemazine Orifarm may in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat / pharynx / mouth or watery discharge, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytos ). It is important that you then inform about your medication.


If you are being treated for diseases other than those for which Alimemazine Orifarm has been prescribed, you should tell your doctor.


Rising age generally leads to an increased sensitivity to drugs. Alimemazine Orifarm 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

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

Other medicines and Alimemazin Orifarm

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

If certain other medicines are taken at the same time, the treatment effect may be affected by Alimemazine Orifarm. Dose one may need to be adjusted by a doctor. 


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

  • Some neuroleptics (remedies for mental illness).
  • Certain remedies for irregular heartbeat (eg quinidine ).
  • Erythromycin, moxifloxacin ( antibiotics ).
  • Methadone (drug used to treat addiction).
  • Mefloquine (malaria remedy).
  • Some antidepressants (tricyclics).
  • Levodopa (a medicine used to treat Parkinson’s disease ).
  • Lithium (a drug used to treat manic conditions and depression).
  • Cisapride (an antidote for gastrointestinal disorders).
  • Some diuretics .

Pregnancy, breastfeeding, and fertility

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


Pregnancy

There is a risk that the fetus is affected. Therefore, always consult a doctor before using Alimemazine Orifarm during pregnancy.


Breast-feeding

Alimemazin Orifarm passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if you are taking Alimemazine Orifarm more than temporarily during breastfeeding.

Driving and using machines

During treatment with Amimelazine Orifarm, the reactivity may be reduced. This should be taken into account when sharper attention is required, e.g. while driving.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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 Orifarm contains sucrose sodium and sucrose

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

May be harmful to teeth.

How to use Alimemazin Orifarm

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

Dose one should be determined by a doctor who adjusts it individually for you. Never exceed the dose prescribed by your doctor.


The recommended dose is:


Anxiety disorders and other symptoms due to alcohol abuse or drug addiction:
 

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.


Itching and allergy s

Adults: 5 mg 2-4 times daily.

Children over 2 years: Dose a matched by age and body weight, and can vary between 2.5 and 15 mg per day, divided into 3 dose s, morning, dinner and evening dose wherein a greater fractional dose given the evening.


In case of vomiting in children over 2 years:
 

2-3 mg 15 minutes before meals 3-4 times a day.
Behavioral disorders and anxiety disorders in children over 2 years of age:

Dose a matched by age and body weight, and can vary between 2.5 and 15 mg per day, divided into 3 dose s, morning, dinner and evening dose wherein a greater fractional dose given the evening.


Sleep disorders

Adults: 10-30 mg 1-2 hours before bedtime.

Children over 2 years: Dose one matched by age and body weight varying between 2.5 and 10 mg at night.


Alimemazine Orifarm oral drops can be mixed with a suitable drink, e.g. juice, juice, coffee, but not milk.


The drops should only be dosed with the supplied dosing pipette. Pipette one is graded 0.25 ml, 0.50 ml, 0.75 ml and 1 ml. One drop with a pipette corresponds to about 1 mg of alimemazine.


The bottle should be resealed immediately after use. NOTE! Only the cap (not the pipette one) is childproof.

The gradation on pipette one Corresponds to the following amount of alimemazine
0.25 ml 10 mg
0.50 ml 20 mg
0.75 ml 30 mg
1 ml 40 mg

If you forget to use Alimemazin Orifarm

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, pharmacist, or nurse.

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 occur only at the beginning of treatment and usually disappear on their own after some time of continued treatment.


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

  • Fatigue, especially at the beginning of treatment.
  • Temporary headache.
  • Nasal congestion.
  • Slight dizziness.
  • Dry mouth can occur. With long-term treatment, this increases the risk of dental and oral mucosal damage. You should therefore take care of your toothbrushing and other oral hygiene extra carefully during treatment with Alimemazin Orifarm.


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

  • Constipation.
  • Difficulty throwing water may occur (especially in older men).
  • Temporary deterioration of visual acuity may occur.


Rare ( may affect up to 1 in 1,000 people):

  • Alimemazine Orifarm may in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe deterioration in general condition or fever with local infection symptoms such as sore throat / throat / mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis / leukopenia). It is important that you then inform about your medication.
  • Especially at higher doses slight tremors, stiffness, twitching or shaking in e.g. 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.
  • Palpitation. effects on heart rhythm, irregular heartbeat and ECG changes associated with it. Cardiac arrest and hypotension with dizziness may occur.
  • Jaundice without liver damage (liver inflammation with yellowing of the skin).
  • High dose and long-term treatment can cause clouding of the lens and cornea of the eye.
  • Fever with muscle stiffness and general effects is a very serious rare side effect.

Has been reported (occurs in unknown number of users

  • Cramps.

Additional side effects in children

Has been reported (occurs in unknown number of users)

  • Respiratory disorders.

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 Orifarm

Keep this medicine out of the sight and reach of children.


The bottle should be resealed immediately after use.

Do not store above 30 ° C.

Store the bottle in the outer carton. Sensitive to light.


Do not use this medicine after the expiry date which is stated on the carton. 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 40 mg / ml.
  • The other ingredients are: peppermint flavor (contains propylene glycol); spearmint flavor; saccharin sodium; citric acid, anhydrous (E330); macrogol glycerol hydroxy stearate, glycerol, sucrose; water.

What the medicine looks like and the contents of the pack

Appearance

Clear, light yellow oral drops.


Pack size 

Brown glass bottle of 50 ml, with PP / PE screw cap (child protection). A glass drop pipette with PP / TPE cap for dosing is included in the package (graded in 0.25 ml, 0.50 ml, 0.75 ml and 1 ml).

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Muhammad Nadeem

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