Patient leaflet - Moxonidine 200 mcg film-coated tablets
What Moxonidine is and what it is used for
Moxonidine is used to treat high blood pressure.
This medicine effects the central nervous system. It works by making your blood vessels relax and widen. This helps to lower your blood pressure.
What you need to know before you take Moxonidine
Do not take Moxonidine if you:
* are allergic to moxonidine or any of the other ingredients of this medicine (listed in section 6)
* have certain heart stimulus disorders known as
- sick sinus syndrome
- AV block 2nd and 3rd degree
* have a pulse of less than 50 beats per minute at rest * have heart failure
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Check with your doctor or pharmacist before taking your medicine if you: * have a heart problem called “1st degree AV- block” or a high risk of developing AV-block
* have a severe heart problem such as angina or chest pain at rest * have kidney problems. Your doctor may need to adjust your dose * are elderly. Your doctor may start you on the lowest dose and increase it gradually.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Children and adolescents
Due to insufficient knowledge, this medicine should not be used by children and adolescents under 16 years.
Other medicines and Moxonidine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* other medicines to lower your blood pressure. The blood pressure-lowering effect may be enhanced.
* beta-blockers (medicines to regulate heart rhythm). See “If you stop taking Moxonidine” in Section 3.
* tranquillisers, sedatives or sleeping tablets such as benzodiazepines. Moxonidine may increase the effect of these medicines. * special medicines for depression, such as imipramine or amitriptyline (tricyclic antidepressants). Avoid using simultaneously with Moxonidine. * Moxonidine is removed from your body by your kidneys through a process called “tubular excretion”. Other medicines removed from the kidneys in the same way could affect how Moxonidine works.
Moxonidine with alcohol
Do not drink alcohol while you are taking Moxonidine. This is because this medicine may increase the effects of alcohol.
Pregnancy and breast-feeding
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.
* Only take Moxonidine during pregnancy if your doctor indicates that it is absolutely necessary, as insufficient data is available. * Moxonidine should not be used if you are breast-feeding, as it passes into mother’s milk. Your doctor may advise you to take another medicine if you want to breast-feed, or may ask you to stop breast-feeding.
Driving and using machines
You may feel sleepy or dizzy while taking this medicine. If this happens, talk to your doctor before driving or using any tools or machines. If your attention is decreased, do not drive or operate machines.
Moxonidine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Moxonidine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
* Starting dose: 200 mcg of moxonidine every morning
* Dosage adjustment
If necessary your doctor can increase the dose to 400 mcg of moxonidine after a 3 week interval (given as a single dose in the morning or divided into one dose in the morning and the second dose in the evening).
In case of insufficient response after a further 3 week treatment, the dose may be increased to a maximum daily dose of 600 mcg of Moxonidine (this dose must be divided into one dose in the morning and the second dose in the evening).
* Maximum dose
You should not take more than 400 mcg as a single dose or more than 600 mcg of moxonidine daily.
* Patients with kidney problems
Your doctor may tell you to take a lower dose if you have kidney problems.
* Duration of use
Your doctor will decide the duration of use.
Take tablets by mouth, whole and with a glass of water. You may take them prior to, with or after meals.
Use in children and adolescents
This medicine should not be given to children and adolescents under 16 years.
Ref: 2653/170326/1/F
1
1
2
2
3
3
4
5
6
Patient Information Leaflet (continued)
If you take more Moxonidine than you should
If you take more medicine than you should, contact your doctor immediately who will decide on further measures, or go to a hospital straight away. Take the medicine pack with you.
The following effects may happen:
* feeling sleepy (sedation, somnolence)
* headache
* feeling dizzy (vertigo)
* fall in blood pressure
* circulatory complaints such as unconsciousness when changing from lying to standing
* slow heart rate
* weakness
* feeling tired
* pain in the stomach (abdominal pain)
* dry mouth
* being sick (vomiting)
* a contradictory rise in blood pressure may occur in rare cases.
If you forget to take Moxonidine
Take the missed dose as soon as you remember, unless it is almost time for your next dose. In that case follow your usual schedule and skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Moxonidine
* Keep taking your tablets until your doctor decides that you should stop. Sudden medicine discontinuation may increase your blood pressure. * If you need to stop, your doctor will lower your dose slowly over a few weeks. If you are taking more than one medicine for high blood pressure (such as beta-blockers), your doctor will tell you which medicine to stop first. This is so that your body can adjust slowly to the change.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Moxonidine and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
* Serious allergic reaction which causes swelling of the face, throat, lips or mouth (angioedema). This is an uncommon side effect, affecting up to 1 in 100 people.
Other side effects include:
Very common, may affect more than 1 in 10 people
* dry mouth
Common, may affect up to 1 in 10 people
* headache
* a feeling of dizziness or “spinning”
* back pain
* rash or itching (pruritus)
* feeling sick (nausea) or being sick (vomiting)
* sleepiness or difficulty in sleeping
* diarrhoea
* indigestion
*weakness
Uncommon, may affect up to 1 in 100 people
* swelling in various body regions
* fall in blood pressure even with dizziness when changing position sudden fainting
* unusually slow heartbeat (bradycardia)
* ringing or noise in the ears (tinnitus)
* neck pain
* feeling nervous
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Moxonidine
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 blister and carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
If your medicine becomes discoloured or shows any other signs of deterioration, ask your pharmacist who will advise you on what to do.
Do not throw away 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.
Contents of the pack and other information
What Moxonidine contains
The active substance is moxonidine.
Each film-coated tablet contains 200 micrograms of moxonidine.
The other ingredients are crospovidone, hypromellose, lactose monohydrate, macrogol 400, magnesium stearate, povidone K25, red iron oxide (E 172), titanium dioxide (E 171).
What Moxonidine looks like and contents of the pack Moxonidine 200 microgram film-coated tablets are light pink, round approximately 6 mm in diameter.
Moxonidine 200 microgram film-coated tablets are available in packs of 30’s.
Manufacturer and Licence Holder
This medicine is manufactured by Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/2653 Moxonidine 200 microgram film-coated tablets
Revision date: 17/03/2026
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet in a format suitable for you
POM
Ref: 2653/170326/1/B
Moxonidine 200 microgram film-coated tablets
4
6
5