20 mg / 40 mg tablets
cinnarizine / dimenhydrinate
1. What Arlevert is and what it is used for
Arlevert contains two active ingredients. One is cinnarizine and the other is dimenhydrinate. The two substances belong to different groups of drugs. Cinnarizine is part of a group called calcium channel blockers. Dimenhydrinate belongs to a group called antihistamines.
Both substances work by reducing the symptoms of vertigo (a feeling of dizziness or that it “spins”) and nausea. When these two substances are used together, they are more effective than when used separately.
Arlevert is used in adults to treat different types of vertigo. Vertigo can have many different causes. The use of Arlevert can help you continue with daily activities that are difficult when you have vertigo.
Cinnarizine and dimenhydrinate found in Arlevert 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 Arlevert
Do not use Arlevert
- if you are under 18 years of age
- if you are allergic to cinnarizine, dimenhydrinate or diphenhydramine, or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other antihistamines (such as astemizole, chlorpheniramine, and terfenadine, which are used as allergy medicines). You should not take this medicine unless your doctor tells you to.
- if you suffer from narrow-angle glaucoma (a special type of eye disease)
- if you have epilepsy
- if you have increased pressure in the brain (eg due to a tumor )
- if you suffer from alcohol abuse
- if you have prostate problems that make it difficult to urinate
- if you have liver or kidney failure.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Arlevert if you suffer from:
- low or high blood pressure
- elevated pressure in the eye
- clogging of the intestines
- enlarged prostate
- overactive thyroid gland
- severe heart disease
- Parkinson’s disease.
The use of Arlevert may make these conditions worse. Arlevert may still be good for you, but your doctor may need to take these facts into account.
Other medicines and Arlevert
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Arlevert may interact with other medicines that you take.
Arlevert may make you tired or drowsy if taken with the medicines listed below:
- barbiturates (medicines that are often taken to calm down)
- narcotic analgesics (strong painkillers such as morphine)
- sedatives (a type of medicine used to treat depression and anxiety)
- monoamine oxidase inhibitors (used to treat depression and anxiety).
Arlevert may increase the effects of the following medicines:
- tricyclic antidepressants (used to treat depression and anxiety)
- atropine (a medicine that is a muscle relaxant and often used to examine the eyes)
- ephedrine (can be used to treat cough or stuffy nose)
- procarbazine (a medicine used to treat certain types of cancer)
- drugs are taken to lower blood pressure et.
Aminoglycosides (a type of antibiotic ) can damage the inner ear. If you take Arlevert, you may not notice this damage.
You should not take Arlevert with medicines used to correct heart problems (antiarrhythmic drugs).
Arlevert can also change the way your skin reacts to your allergy test.
Delivered with food, drink, and alcohol
Arlevert can cause stomach upset, which can be reduced by taking the tablets after a meal. Do not drink alcohol while taking Arlevert, as it may make you tired or sleepy.
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.
Driving and using machines
Arlevert can make you sleepy. If this happens, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
3. How to use Arlevert
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 one tablet three times daily, along with some liquid after a meal. Swallow the tablet whole, do not chew it.
Arlevert is usually taken for up to 4 weeks. Your doctor will tell you if you need to take Arlevert for longer than that.
If you take too many Arlevert, you may become very tired, dizzy, and shaky. Your pupils may dilate and you may not be able to urinate. Your mouth may feel dry, your face may blush, you may experience a faster heart rate, fever, sweating, and headache.
If you have taken a large amount of Arlevert, you may have seizures, hallucinations, high blood pressure, feel shaky, get aroused, and find it difficult to breathe. Company occurs.
If you forget to use Arlevert
If you forget to take an Arlevert tablet, skip that tablet. Take the next tablet Arlevert next time you would normally take it. Do not take a double dose to make up for a forgotten tablet.
If you stop using Arlevert
Do not stop taking Arlevert before your doctor tells you to. You will probably get symptoms of vertigo again (dizziness and “spinning”) if you stop treatment too soon.
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, Arlevert can cause side effects, although not everybody gets them.
Common side effects are (may affect up to 1 in 10): drowsiness, dry mouth, headache, and abdominal pain. These are usually mild and disappear within a few days, even if you continue to take Arlevert.
Less common side effects are (may affect up to 1 in 100): sweating, flushing, upset stomach, nausea, diarrhea, nervousness, seizures, forgetfulness, tinnitus (ringing in the ears), paresthesia (tingling in the hands or feet), tremor ( tremor).
Rare side effects are (may affect up to 1 in 1000): impaired vision, allergic reactions (eg, skin reactions), light sensitivity, and difficulty in urination.
Very rare side effects are (may affect up to 1 in 10 000 users): the number of white blood cells and platelets may be lower, and the number of red blood cells may drop sharply, which can cause weakness, bruising, or increase the risk of infection you. If you get an infection with a fever and a severe general condition, consult your doctor and tell him about your medicine.
Other possible reactions (occurring in an unknown number of users) that may occur with this type of medicine include:
weight gain, constipation, feeling of pressure over the chest, jaundice (yellowing of the skin or whites of the eyes caused by problems with the liver or blood), worsening narrow-angle glaucoma (eye disease with increased pressure inside the eye), uncontrollable movements, unusual arousal and restlessness (especially in children), severe skin reactions.
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 Arlevert
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 and blister after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater. 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 substances are cinnarizine (20 mg) and dimenhydrinate (40 mg).
The other ingredients are: microcrystalline cellulose, maize starch, talc, hypromellose, colloidal anhydrous silica, magnesium stearate, and croscarmellose sodium.
What the medicine looks like and the contents of the pack
Arlevert tablets are round, biconvex, white to pale yellow tablets marked with an “A” on one side, with a diameter of 8 mm. They are available in packs containing 20, 50, or 100 tablets. The tablets are packaged in PVC / PVDC / aluminum blisters containing 20 or 25 tablets, as appropriate, Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
HENNIG ARZNEIMITTEL GmbH & Co. KG, Liebigstrasse 1-2, 65439 Flörsheim am Main, Germany.
Local representative:
Immedica Pharma AB, Norrtullsgatan 15, SE 111 29 Stockholm. Phone number +46 8 533 39 500. Email info@immedica.com