Mediclarum
Medicine guide

Rivastigmine Hexal

·

  • Prescription status not stated
  • Pain, sleep, mood, epilepsy and the brain
Active substance
Rivastigmine
Made by
Hexal AG

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • The active substance of Rivastigmine HEXAL is rivastigmine.
  • Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
  • In patients with Alzheimer’s dementia or dementia due to Parkinson’s disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase. By blocking these enzymes, Rivastigmine allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer’s disease and dementia associated with Parkinson’s disease.
  • Rivastigmine HEXAL is used for the treatment of adult patients with mild to moderately severe Alzheimer’s dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour. The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson’s disease.

From the package leaflet in EMA’s product information, p. 49 · 2026-08-20

Do not take it if

  • if you are allergic to rivastigmine (the active substance in Rivastigmine HEXAL) or any of the other ingredients of this medicine (listed in section 6).
  • if you have had a previous skin reaction suggestive of allergic contact dermatitis with rivastigmine.
  • If this applies to you, tell your doctor and do not take Rivastigmine HEXAL.

From the package leaflet in EMA’s product information, p. 49.

Warnings and precautions

  • Talk to your doctor before taking Rivastigmine HEXAL
  • if you have, or have ever had, a heart condition such as an irregular or slow heartbeat, QTc prolongation, a family history of QTc prolongation, torsade de pointes, or have a low blood level of potassium or magnesium.
  • if you have, or have ever had, an active stomach ulcer.
  • if you have, or have ever had, difficulties in passing urine.
  • if you have, or have ever had, seizures.
  • if you have, or have ever had, asthma or severe respiratory disease.
  • if you have, or have ever had impaired kidney function.
  • if you have, or have ever had, impaired liver function.
  • if you suffer from trembling.
  • if you have a low body weight.
  • if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea. You may become dehydrated (losing too much fluid) if vomiting or diarrhoea are prolonged.
  • If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
  • Children and adolescents There is no relevant use of Rivastigmine HEXAL in the paediatric population in the treatment of

From the package leaflet in EMA’s product information, p. 50.

Pregnancy and breastfeeding

  • 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.
  • If you are pregnant, the benefits of using Rivastigmine HEXAL must be assessed against the possible effects on your unborn child. Rivastigmine HEXAL should not be used during pregnancy unless clearly necessary.
  • You should not breast-feed during treatment with Rivastigmine HEXAL.

From the package leaflet in EMA’s product information, p. 50–51.

Other medicines

  • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
  • Rivastigmine Hexal should not be given at the same time as other medicines with similar effects to Rivastigmine HEXAL. Rivastigmine HEXAL might interfere with anticholinergic medicines (medicines used to relieve stomach cramps or spasms, to treat Parkinson’s disease or to prevent travel sickness).
  • Rivastigmine Hexal should not be given at the same time as metoclopramide (a medicine used to relieve or prevent nausea and vomiting). Taking the two medicines together could cause problems such as stiff limbs and trembling hands.
  • If you have to undergo surgery whilst taking Rivastigmine HEXAL, tell your doctor before you are given any anaesthetics, because Rivastigmine HEXAL may exaggerate the effects of some muscle relaxants during anaesthesia.
  • Caution when Rivastigmine HEXAL is taken together with beta-blockers (medicines such as atenolol used to treat hypertension, angina and other heart conditions). Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.
  • Caution when Rivastigmine HEXAL is taken together with other medicines that can affect your heart rhythm or the electrical system of your heart (QT prolongation).

From the package leaflet in EMA’s product information, p. 50.

Driving and using machines

  • Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.
  • Rivastigmine HEXAL may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
  • Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
  • How to start treatment Your doctor will tell you what dose of Rivastigmine HEXAL to take.
  •  Treatment usually starts with a low dose.
  •  Your doctor will slowly increase your dose depending on how you respond to treatment.
  •  The highest dose that should be taken is 6.0 mg twice a day.
  • Your doctor will regularly check if the medicine is working for you. Your doctor will also monitor your weight whilst you are taking this medicine.
  • Taking this medicine  Tell your caregiver that you are taking Rivastigmine HEXAL.
  •  To benefit from your medicine, take it every day.
  •  Take Rivastigmine HEXAL twice a day in the morning and evening with food.
  •  Swallow the capsules whole with a drink.
  •  Do not open or crush the capsules.
  • If you take more Rivastigmine HEXAL than you should If you accidentally take more Rivastigmine HEXAL than you should, inform your doctor. You may require medical attention. Some people who have accidentally taken too much Rivastigmine HEXAL have experienced feeling sick (nausea), being sick (vomiting), diarrhoea, high blood pressure and hallucinations. Slow heartbeat and fainting may also occur.
  • If you forget to take Rivastigmine HEXAL If you find you have forgotten to take your dose of Rivastigmine HEXAL, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • You may have side effects more often when you start your medicine or when your dose is increased.
  • Usually, the side effects will slowly go away as your body gets used to the medicine.
  •  Feeling dizzy  Loss of appetite  Stomach problems such as feeling sick (nausea) or being sick (vomiting), diarrhoea  Sweating  Headache  Heartburn  Weight loss  Stomach pain  Feeling agitated  Feeling tired or weak  Generally feeling unwell  Trembling or feeling confused  Decreased appetite  Nightmares  Sleepiness  Fainting or accidentally falling  Changes in how well your liver is working Rare (may affect up to 1 in 1,000 people)
  •  Chest pain  Rash, itching  Fits (seizures)
  •  Ulcers in your stomach or intestine Very rare (may affect up to 1 in 10,000 people)
  •  Urinary tract infection  Problems with your heartbeat such as fast or slow heartbeat  Bleeding in the gut – shows as blood in stools or when being sick  Inflammation of the pancreas – the signs include serious upper stomach pain, often with feeling sick (nausea) or being sick (vomiting)
  • difficulty in carrying out movements  Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with your stomach (oesophagus)
  •  Dehydration (losing too much fluid)
  •  Liver disorders (yellow skin, yellowing of the whites of the eyes, abnormal darkening of the urine or unexplained nausea, vomiting, tiredness and loss of appetite)
  •  Aggression, feeling restless  Uneven heartbeat Patients with dementia and Parkinson’s disease These patients have some side effects more often. They also have some additional side effects:
  •  Trembling  Fainting  Accidentally falling  Feeling restless  Slow and fast heartbeat  Too much saliva and dehydration  Unusually slow movements or movements you cannot control difficulty in carrying out movements and muscle weakness  Uneven heartbeat and poor control of movements  Low blood pressure  Skin rash Other side effects seen with transdermal patches and which may occur with the hard capsules:
  •  Fever  Severe confusion  Urinary incontinence (inability to retain adequate urine)
  •  Hyperactivity (high level of activity, restlessness)
  •  Allergic reaction where the patch was used, such as blisters or skin inflammation If you get any of these side effects, contact your doctor as you may need medical assistance.
  • 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 51–53.

How to store it

  • Keep this medicine out of the sight and reach of children.
  • Do not use Rivastigmine HEXAL after the expiry date which is stated on the blister, bottle label and carton after “EXP”. The expiry date refers to the last day of that month.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
  • 6. Content of the pack and other information What Rivastigmine HEXAL contains
  • The active substance is rivastigmine.
  • The other ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide red iron oxide, titanium dioxide, and shellac.
  • Each Rivastigmine HEXAL 1.5 mg capsule contains 1.5 mg of rivastigmine.
  • Each Rivastigmine HEXAL 3 mg capsule contains 3 mg of rivastigmine.
  • Each Rivastigmine HEXAL 4.5 mg capsule contains 4.5 mg of rivastigmine.
  • Each Rivastigmine HEXAL 6 mg capsule contains 6 mg of rivastigmine.
  • What Rivastigmine HEXAL looks like and contents of the pack
  • Rivastigmine HEXAL 1.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a yellow cap and yellow body, with a red imprint “RIV 1.5 mg” on the body.
  • Rivastigmine HEXAL 3 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “RIV 3 mg” on the body.
  • Rivastigmine HEXAL 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “RIV 4.5 mg” on the body.
  • Rivastigmine HEXAL 6 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “RIV 6 mg” on the body.
  • They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) but these may not all be available in your country.
  • Marketing Authorisation Holder Manufacturer Gran Via de les Corts Catalanes, 764 90429 Nürnberg For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
  • België/Belgique/Belgien Luxembourg/Luxemburg Sandoz nv/sa Sandoz nv/sa Tél/Tel.: + 32 2 722 97 97 Tél/Tel: + 32 2 722 97 97 България Magyarország Сандоз България КЧТ Sandoz Hungária Kft.k Teл.: + 359 2 970 47 47 Bartók Béla út 43-47 H-1114 Budapest Tel.: + 36 1 430 2890 E-mail: info.hungary@sandoz.com Česká republika Malta Sandoz s.r.o. Sandoz Pharmaceuticals d.d.
  • Tel: +420 234 142 222 Tel: +35699644126 Danmark Nederland Sandoz A/S Sandoz BV Tlf.: + 45 63 95 10 00 Hospitaaldreef 29, NL-1315 RC Almere Tel: +31 36 5241600E-mail: info.sandoz- nl@sandoz.com Deutschland Norge Hexal AG Sandoz A/S D-83607 Holzkirchen Tlf: + 45 63 95 10 00 Tel: + 49 8024 908 0 E-mail: service@hexal.com Eesti Österreich Sandoz d.d. Eesti filiaal Hexal GmbH Tel: +372 6652400 Jakov-Lind-Straße 5, Top 3.05 A-1020 Wien Tel: + 43 (0)1 486 96 22 Ελλάδα Polska SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Sandoz Polska Sp.z o.o.
  • Α.Ε. ul. Domaniewska 50 C Τηλ: +30 216 600 5000 PL-02-672 Warszawa Tel: + 48 22 549 15 00 España Portugal Sandoz Farmacéutica, S.A Sandoz Farmacêutica Lda.
  • Centro Empresarial Parque Norte, Edificio Roble Tel: +351 21 196 40 00 C/ Serrano Galvache Nº 56, 28033 Madrid Tel: +34 900 456 856 registros.spain@sandoz.com France România Sandoz SAS Sandoz Pharmaceuticals SRL Tél: + 33 1 49 64 48 00 Tel: +40 21 407 51 60 Ireland Slovenija Rowex Ltd. Lek Pharmaceuticals d.d.
  • Newtown Verovškova 57 IE-Bantry Co. Cork SI-1526 Ljubljana P75 V009 Tel: + 386 1 5802111 Tel: +353 27 50077 E-mail: info.lek@sandoz.com Email: patient.safety.ireland@sandoz.net Ísland Slovenská republika Sandoz A/S Sandoz d.d. - organizačná zložka Žižkova 22B Simi: + 45 63 95 10 00 SK-811 02 Bratislava Tel: +421 2 48 200 600 Italia Suomi/Finland Sandoz S.p.A. Sandoz A/S Tel: + 39 02 812 806 96 Puh/Tel: + 358 10 6133 400 Κύπρος Sverige SANDOZ HELLAS ΜΟΝΟΠΡΟΣΩΠΗ Α.Ε. Sandoz A/S (Ελλάδα)
  • Τηλ: +30 216 600 5000 Tel: + 45 63 95 10 00 Latvija Sandoz d.d. Latvia filiāle K.Valdemāra Str. 33 – 29 LV-1010 Riga Tel: + 371 67892006 Lietuva Hrvatska Sandoz Pharmaceuticals d.d. filialas Sandoz d.o.o.
  • Tel: + 370 5 2636037 Maksimirska 120 10 000 Zagreb Tel: +38512353111 E-mail: upit.croatia@sandoz.com This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency (EMA)
  • website: http://www.ema.europa.eu/

From the package leaflet in EMA’s product information, p. 53–56.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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United StatesNo exact match for this strength and form

Every strength and form (67)

BulgariaNo exact match for this strength and form

Every strength and form (2)

SpainNo exact match for this strength and form

Every strength and form (144)

FranceNo exact match for this strength and form

Every strength and form (11)

CanadaNo exact match for this strength and form

Every strength and form (35)

NetherlandsNo exact match for this strength and form

Every strength and form (75)

SwitzerlandNo exact match for this strength and form

Every strength and form (22)

Details

Made byHexal AG
Active substanceRivastigmine
Used inPain, sleep, mood, epilepsy and the brain
ClassificationN06DA03 · Pain, sleep, mood, epilepsy and the brain
Authorised on2009-12-11
Last updated by the regulator2026-08-20
EMA product numberEMEA/H/C/001182

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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