Clonidine

• Prevents hot flashes (menopause) and high blood pressure
• Also used for withdrawal symptoms and prevention of migraine
• Can cause drowsiness
• Avoid drinking alcohol while taking this medicine

The active ingredient clonidine hydrochloride belongs to a group of medicines called ‘vasodilators’, which cause widening of the blood vessels and therefore a reduction in blood pressure. It is prescribed by doctors for:

• Hot flashes that may occur in women during the menopause.
• High blood pressure.
• Withdrawal symptoms after abusing (prescription) drugs.
• Preventing migraine attacks.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Clonidine tablets should be taken with a drink of water, with or without food. The tablets should be taken at the same time each day to avoid missing a dose.

A dose may not be increased or decreased suddenly. Adjustment of your dose should be done gradually to avoid a sudden drop or increase in blood pressure.

Dosage

Your dose should be determined by a doctor, depending on the condition being treated. The general guidelines for use are as follows:

For hot flashes during menopause

• The recommended starting dose is 0.050 to 0.075 mg twice a day, preferably spaced 12 hours apart. If the effect of three to four weeks of treatment is inadequate, treatment should be discontinued.

For high blood pressure

• The recommended starting dose is 0.075 mg three times a day. Your doctor may adjust the dose depending on your response. The maximum dose will not exceed 0.450 mg a day. A higher dose may be necessary in special cases which usually require hospital treatment. In these cases, the highest daily dose is 1.8 mg.

For drug withdrawal symptoms

• The usual initial dose is 0.2 mg to 0.5 mg a day, divided in approx. two to four doses. This dose may be increased with 0.1 to 0.3 mg a day up to a maximum of 1.2 mg a day depending on the effect and the patient's blood pressure. Treatment can be discontinued gradually over two to three days after seven days of treatment.

For migraine attacks

• The recommended starting dose is 0.025 mg once daily. After two weeks of treatment, this dose may be increased up to a maximum of 0.050 mg a day. Doses of 0.075 mg twice a day may be prescribed in exceptional cases.

Alcohol/driving

You may feel drowsy or dizzy, especially in first few weeks of using Clonidine. As a result, your reaction time may be slower. If affected, you should not drive, operate machinery or take part in any activities where these reactions may put you or others at risk.

Limit or stop drinking alcohol while taking this medicine as this is likely to trigger or worsen side effects such as drowsiness.

If you take more Clonidine than you should/stop taking Clonidine

If you have taken more Clonidine tablets than you should, contact your doctor or pharmacistimmediately. Symptoms of overdose include low blood pressure, slow heart rate, drowsiness or sleepiness. Take your medicine pack and the package leaflet with you.

If you miss a dose of Clonidine, take it as soon as you remember unless it is almost time for the next dose. Continue your dosing schedule as usual. Never take a double dose to make up for the forgotten one.

Do not stop taking Clonidine without consulting your doctor first. Discontinuation of treatment should be done gradually to avoid a sudden increase in blood pressure causing symptoms such as excitement, palpitations, insomnia and tremor.

Clonidine is not suitable for everyone. Do not take this medicine:

• If you are allergic to any of the ingredients in this medicine (see section 'What Clonidine contains').
• If you have a slow heart rate resulting from a disease of the heart called sicksinus syndrome.
• If you have, or have had, kidney problems, Clonidine should not be used to treat withdrawal symptoms.
• If you have, or have had, low blood pressure, Clonidine should not be used to treat withdrawal symptoms.

When should this medicine be used with caution?

Take special care with using Clonidine in the following situations:

• At the start of the treatment. You may experience side effects such as sleepiness and drowsiness. This may affect your ability to react.
• If you have a decreased kidney function. Have your kidney function monitored regularly while taking this medicine.
• If you stop taking this medicine or adjust the dose. Adjustment of your dose should be done gradually to avoid a sudden drop or increase in blood pressure. It is important to have your blood pressure and heart rate monitored regularly.
• If serious abnormalities of the blood vessels in the brain have been detected during the treatment of high blood pressure. In such case, treatment with Clonidine should start at a low dose and be frequently reviewed by a doctor.

Talk to a doctor if any of these situations apply to you or if you have a history of these conditions.

Pregnancy and breastfeeding

Do not use Clonidine if you are pregnant or breastfeeding without consulting a doctor first. This medicine passes into breast milk in small amounts.

Other medicines and Clonidine

Some medicines can interact with Clonidine which can significantly alter their effects and side effects:

• Medicines used to relieve anxiety such as tranquillisers, hypnotics and also alcohol may increase drowsiness caused by Clonidine.
• Medicines which are used to lower the blood pressure may increase the hypotensive effects of Clonidine.

Be sure to tell your doctor if you are taking or have recently taken these or any other medicines. This includes medicines that do not require a prescription.

Just like all medicines, Clonidine may cause side effects. The following are some of the side effects that are known to be associated with this medicine:

• Drowsiness, sleepiness, tiredness. Normally, these symptoms disappear if you continue treatment. In some cases it may be necessary to reduce the dose.
• Dry mouth.
• Dizziness.
• Gastrointestinal symptoms (nausea, loss of appetite, constipation).
• Restlessness.
• Skin redness.
• Pain below the ear (from the salivary gland).
• Low pulse rate.
• High doses (migraine, hot flashes, withdrawal symptoms): drop in blood pressure.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The active substance is clonidine hydrochloride. Clonidine tablets come in three strengths: 0.025, 0.100 and 0.150 mg.

The other ingredients are: calcium hydrogen phosphate (E341), lactose, maize starch, sodium carboxymethyl starch (E466), polyvidone (E1201), magnesium stearate (E470b), anhydrous colloidal silicon dioxide (E551).

The 0.025-mg tablets also contain hypromellose (E464), propylene glycol (E1520), titanium dioxide (E171), talc (E553b), indigo carmine (E132).

The 0.100-mg tablets also contain Quinoline Yellow WS (E104).

The marketing authorisation holder of Clonidine is:

Centrafarm Services B.V. Nieuwe Donk 9
4879 AC Etten-Leur
The Netherlands

Read the package leaflet before use. The official package leaflet of Clonidine is available for download here.