Lergigan mite 5 mg, Lergigan 25 mg, Lergigan forte 50 mg film-coated tablets
promethazine hydrochloride
What Lergigan is and what it is used for
Lergigan contains promethazine and belongs to the group of antihistamines.
Lergigan 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, Lergigan also has a calming effect. Lergigan is not addictive.
Lergigan is used against:
- Tension and anxiety in nervous disorders.
- Alcohol abuse.
- Sleep disorders.
- Severe anxiety and as a sedative before surgery and dental procedures.
- Motion sickness, such as seasickness.
- Skin itching and allergies .
- Nausea and dizziness.
- Excessive elation.
What you need to know before using Lergigan
Do not use Lergigan
- if you are allergic to prometazine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Lergigan:
- if you suffer from an enlarged prostate
- if you suffer from narrowing of the urethra
- if you suffer from narrowing of the lower gastrointestinal tract and duodenum (pyloroduodenal obstruction )
- if you have jaundice ( hepatitis )
- if you have myasthenia gravis (severe muscle weakness)
- if you suffer from cardiovascular disease or changes in heart rhythm
- if you have a risk of cerebral haemorrhage ( stroke )
Due to dry mouth (which is a common side effect), there is a risk of tooth and oral mucosal damage, especially with prolonged use. You should therefore brush your teeth thoroughly with fluoride toothpaste twice daily.
Treatment with Lergigan can cause problems for contact lens wearers due to reduced tear flow.
Other drugs and Lergigan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.
Lergigan may affect or be affected if taken concomitantly with certain other medicinal substances against:
- arrhythmias in the heart (eg flecainide and amiodarone )
- certain antibiotics (moxifloxacin and erythromycin)
- pain conditions (eg methadone )
- malaria drug (meflokin)
- intestinal disease (eg cisapride)
- mental disorders (eg lithium and neuroleptics such as haloperidol , clozapine and risperidone )
- depression ( tricyclic antidepressants )
- anxiety (eg diazepam )
Avoid concomitant treatment with certain diuretics (thiazide diuretics), as these may reduce the level of potassium in the blood and thus increase the risk of arrhythmias in the heart.
Lergigan with food, drink and alcohol
Concomitant use of alcohol and central depressants should be avoided due to the risk of the enhanced effect of Lergigan.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
No adverse effects on the fetus have been demonstrated.
Breast-feeding
It is not known if promethazine hydrochloride passes into breast milk. Therefore, consult a physician before regular use during breastfeeding.
Driving and using machines
During treatment with Lergigan, the ability to react 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 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.
Lergigan mite contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Lergigan
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the physician, who adjusts it individually for each patient. The usual dose of tablets is:
Nervous conditions: Adults: 5-50 mg 1-3 times daily. Children: 2-5 years: 5 mg 1-3 times daily, children 5-12 years: 10 mg 1-3 times daily.
Severe anxiety and hyperactivity: Adults: 25-50 mg, up to 400-500 mg per day.
Sleep disorders: Adults: 25-50 mg at night. Children 2-5 years: 5-20 mg at night, children 5-12 years: 20-25 mg at night. Sometimes the medication is interrupted every three or four nights.
Motion sickness: Adults: 25 mg 1-2 hours before the trip or the evening before the trip. If necessary, two more doses can be taken in one day.
Children: 2-5 years: 5 mg 1-2 hours before the trip or the evening before the trip. If necessary, two more doses can be taken in one day.
Children 5-12 years: 10 mg 1-2 hours before the trip or the evening before the trip. If necessary, two more doses can be taken in one day.
Allergic conditions: Adults: 25 (-50) mg at night. Children 2-5 years: 5 mg 1-3 times daily, children 5-12 years: 10 mg 1-3 times daily.
Possible side effects
Like all medicines, Lergigan can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people ) : Drowsiness. Dry mouth. When Lergigan is taken at night, you may feel a little drowsy the next morning. This disappears after a few days of treatment.
Uncommon (may affect up to 1 in 100 people): Difficulty disposing of water. Constipation. Difficulties for the eye to switch between near and far vision. Reduced tear flow.
Rare (may affect up to 1 in 1,000 people): Jaundice without signs of liver damage. Effects on heart rate, irregular heartbeat, and ECG changes associated with it. Cardiac arrest.
How to store Lergigan
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 carton. The expiration date is the last day of the specified month.
The medicine 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.
Contents of the pack and other information
Content declaration
- The active substance is : promethazine hydrochloride 5 mg, 25 mg and 50 mg respectively.
- Other ingredients are: titanium dioxide (E171), glycerol , vanilla flavor, magnesium stearate, sorbitan oleate, anhydrous colloidal silica, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, ethyl cellulose, hydroxypropyl cellulose, macrogol 8000, crospovidone (not included in Lergigan mite ). Lergigan mite also contains sodium starch glycolate.
What the medicine looks like and contents of the pack
Lergigan mite 5 mg:
White, round, film-coated tablet, cupped, with embossing LM within arches, diameter 6 mm. 30 pcs and 100 pcs in plastic jars with child-resistant lids.
Lergigan 25 mg:
White, round, film-coated tablet, cupped, with embossing LE in frames, diameter 6 mm. 30 pcs and 100 pcs in plastic jars with child-resistant lids.
Lergigan forte 50 mg:
White, round, film-coated tablet, cupped, with embossing LF within arches, diameter 6 mm. 100 pcs in plastic jars with child-resistant lids.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Meda AB
Box 906
170 09 Solna
Phone: 08-630 19 00
Email: info@meda.se