Package Insert: Information for the Patient

Catapresan 0.150 mg Tablets

Clonidine Hydrochloride

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Catapresan contains an active ingredient called clonidine, which belongs to a group of medications known as imidazoline receptor agonists (medications that lower blood pressure).

Catapresan is used for the treatment of high blood pressure in all its forms.

Do not take Catapresan:

• if you are allergic to hydrochloride of clonidine or to any of the other components of this medication (listed in section 6)
• if you have severe bradycardia (slow heart rate).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Catapresan:

• if you have mild or moderate bradycardia (slow heart rate)
• if you have cerebral or peripheral circulation disorders
• if you have depression
• if you have polyneuropathy (a type of nervous system disorder)
• if you have constipation
• if you have renal insufficiency (see section 3)
• if you are considering interrupting treatment (see section 3)
• if your treatment is associated with a beta-blocker (medication used in the treatment of high blood pressure and heart problems). In this case, follow the doctor's instructions to interrupt treatment
• if you have heart problems such as heart failure or severe coronary disease. In this case, as with other medications used to treat high blood pressure, you should undergo a careful medical follow-up
• if you wear contact lenses as this medication may reduce tear production.

It is not expected that clonidine will have any therapeutic effect if you have hypertension caused by phaeochromocytoma (a disease that can lead to an increase in blood pressure).

Children and adolescents

Do not administer Catapresan to children and adolescents. Specifically, if it is used outside of the authorized conditions along with methylphenidate (a medication to treat attention deficit hyperactivity disorder (ADHD) in children), severe adverse reactions have been observed, including death.

Taking Catapresan with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly inform your doctor if you are taking any of the following types of medications:

• Other medications intended to lower blood pressure: the decrease in blood pressure produced by this medication may be potentiated.

• Non-steroidal anti-inflammatory drugs: the effect of this medication may be reduced.

• Medications with alpha 2 blocking properties such as fentolamine or tolazoline: the effect of this medication may be cancelled.

• Beta-blockers and digitalis derivatives (medications used to treat high blood pressure and heart problems) may produce or increase bradycardia (slow heart rate) when administered at the same time as clonidine. Additionally, beta-blockers may cause or exacerbate peripheral circulation disorders.

• Tricyclic antidepressants (used in the treatment of depression) or neuroleptics (for the treatment of some mental disorders): the concurrent administration with this medication may cause or worsen orthostatic regulation disorders (changes in blood pressure when changing position) and may also reduce or cancel the hypotensive effect of clonidine.

Clonidine may potentiate the effects of central nervous system depressants (also called sedatives or tranquilizers).

Taking Catapresan with food, drinks, and alcohol

Clonidine may potentiate the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

During pregnancy, clonidine should only be used in extreme necessity, with a careful monitoring of the mother and the child, as clonidine may reduce fetal heart rate and cause a temporary increase in blood pressure in the newborn after delivery.

No adequate experience is available regarding the long-term effects of prenatal exposure.

During breastfeeding, the use of this medication is not recommended, as there is not enough information available.

No data is available on the effect of clonidine on fertility.

Driving and operating machinery

Catapresan may cause drowsiness, drowsiness, and accommodation disorders (difficulty focusing the eye). Therefore, caution is recommended when driving or operating machinery.

Catapresan contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Regular medical supervision is required for hypertension treatment.

The Catapresan dose will be established according to the blood pressure response of each patient.

Most mild and moderate hypertension cases respond to a medium dose of 2 tablets per day, one in the morning and one at night before sleeping. It is recommended to start treatment with 1 tablet at night and after 10-15 days to follow with one in the morning and one at night.

In case of need, the dose can be increased after a period of 2-4 weeks to achieve the desired response, preferably at night.

In cases of severe hypertension, it may be necessary to increase each dose up to 2 tablets (0.3 mg); this dose can be repeated up to four times a day (8 tablets=1.2 mg).

Tablets should be taken with a little liquid.

The tablet can be divided into equal doses.

Renal Insufficiency

The dose should be established according to:

• the individual anti-hypertensive response, which may undergo significant variations in patients with renal insufficiency
• the degree of renal deterioration

Monitoring is required in both cases.

Since only a minimal amount of clonidine is eliminated during routine hemodialysis, it is not necessary to administer a supplementary dose of clonidine after dialysis.

If you take more Catapresan than you should

The symptoms due to an overdose include pupil constriction, lethargy, slow heart rate, hypotension, decreased body temperature, sleep (including coma) and decreased respiratory rate.

It may also cause an increase in blood pressure.

If you take more Catapresan than you should, consult your doctor, pharmacist or call the Toxicological Information Service at 91 562 04 20 immediately.

If you forgot to take Catapresan

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Catapresan

Do not stop treatment abruptly without consulting your doctor, as after prolonged treatment at high doses, restlessness, palpitations, rapid increase in blood pressure, nervousness, tremors, headaches or nausea may appear.

Follow your doctor's instructions to stop treatment if you are taking it associated with a beta-blocker.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects are mostly mild and tend to decrease as treatment continues.

The very common adverse effects (occurring in more than 1 in 10 patients) are dizziness, sedation, decreased blood pressure when changing from a seated to a standing position (orthostatic hypotension), and dry mouth.

The common adverse effects (occurring in 1 to 10 in 100 patients) are depression, sleep disorders, headache, constipation, nausea, vomiting, salivary gland pain, difficulty achieving or maintaining an erection, and fatigue.

The uncommon adverse effects (occurring in 1 to 10 in 1,000 patients) are delirium, hallucinations, nightmares, sensation of skin tingling (paresthesia), slow heart rate (sinus bradycardia), blockage of blood circulation causing pain and color changes, especially in the fingers and toes (Raynaud's phenomenon), itching, rash, urticaria, and discomfort.

In rare cases (occurring in 1 to 10 in 10,000 patients), an increase in breast size (gynecomastia), reduced tear production, (atrioventricular block), dry nose, generalized intestinal movement disorder (pseudoobstruction of the colon), hair loss, and increased blood sugar levels have been observed.

The adverse effects of unknown frequency are confusion, decreased libido, difficulty focusing the eye, and decreased heart rate (bradyarrhythmia).

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Catapresan

• The active ingredient is hydrochloride of clonidine. Each tablet contains 0.150 mg of hydrochloride of clonidine.
• The other components are lactose, calcium phosphate, dried cornstarch, soluble cornstarch, colloidal silicon dioxide, polyvinylpyrrolidone and stearic acid.

Appearance of the product and contents of the packaging

Catapresan are white, round, beveled-edge tablets on both sides. One side has the imprint 15C/15C or N/150 and a score.

Packaging with 30 tablets.

Holder of the marketing authorization

Glenwood GmbH Pharmazeutische Erzeugnisse

Arabellastr.17

81925 Munich

Germany

Responsible for manufacturing

Delpharm Reims S.A.S.

10 rue Colonel Charbonneaux

51100 Reims

France

Last review date of this leaflet: July 2013

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/