Catapresan

Package leaflet: Information for the patient

Catapresan 150 micrograms/ml injectable solution

Clonidine hydrochloride
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Catapresan is and what it is used for
2. What you need to know before being given Catapresan
3. How to use Catapresan
4. Possible side effects
5. How to store Catapresan
6. Contents of the pack and other information

1. What Catapresan is and what it is used for

Catapresan is a medicine containing the active substance clonidine hydrochloride, which works by reducing high blood pressure (hypertension).
Catapresan is indicated for adults aged 18 years and older in the following cases:

• hypertensive crises (sudden increases in blood pressure)
• hypertension where oral therapy is ineffective or cannot be used.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Catapresan

Do not use Catapresan

• if you are allergic to clonidine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from very slow and irregular heartbeat (severe bradyarrhythmia) due to heart rhythm disorders (sinoatrial disease or severe atrioventricular block).

Warnings and precautions
This medicine will be administered to you in hospital under close supervision by qualified healthcare personnel.
Before using Catapresan, inform your doctor:

• if you suffer from severe heart disease characterized by obstruction of the coronary arteries, the blood vessels supplying blood to the heart (severe coronary insufficiency)
• if you suffer from severe kidney disease (chronic renal failure)
• if you suffer from diseases causing disturbances in blood flow to the brain (cerebrovascular diseases)
• if you recently had a heart attack
• if you suffer from a condition causing your heartbeat to be slower than normal (mild or moderate bradyarrhythmia)
• if you suffer from constipation
• if you suffer from a disease characterized by gradual and progressive loss of muscle strength and/or sensory disturbances in arms and legs (polyneuropathy)
• if you suffer from a disease manifesting with spasms of the arteries in fingers and toes (Raynaud's disease) and/or other disorders causing disturbances in blood circulation in the body
• if you suffer from or have suffered from depression.

If you suffer from phaeochromocytoma
If you have a disease characterized by the release in the body of substances that increase blood pressure
(phaeochromocytoma), the use of Catapresan is not effective.
If you have reduced kidney function (renal insufficiency)
If you suffer from renal insufficiency, the dosage of Catapresan must be carefully determined by your doctor
(see section 3, "How to use Catapresan").
If you have reduced heart function (heart failure or severe coronary heart disease)
If you suffer from severe heart failure or coronary heart disease (severe heart conditions), treatment with Catapresan must be closely monitored by your doctor, as with other medicines that lower blood pressure.
Contact lenses
Treatment with Catapresan may reduce tear production; you should take this into account if you wear contact lenses.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended, as safety and efficacy have not been established.
Despite Catapresan not being recommended in children and adolescents, if your doctor prescribes it for your child, please note that the use of clonidine in children and adolescents under 18 years of age in combination with a medicine used in children for the treatment of attention deficit hyperactivity disorder (methylphenidate) may cause serious adverse effects including death.
Other medicines and Catapresan
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Catapresan may interact with other medicines taken concurrently, such as:

• other medicines used to lower blood pressure, as they may enhance the effect of Catapresan. Your doctor may use this interaction to help lower your blood pressure

• medicines that cause an increase in blood pressure (such as non-steroidal anti-inflammatory drugs, pain and anti-inflammatory medicines), as they may reduce the effect of clonidine

• substances that may increase blood pressure (such as phentolamine or tolazoline), as they may interfere with the effects of clonidine

• substances that slow down the heart rate or rhythm (such as beta-blockers or digitalis glycosides), as in situations where the number of heartbeats per minute is reduced (bradycardia), these medicines may cause or worsen heart rhythm disorders

• beta-blockers, as they may cause or worsen disorders of blood vessels outside the heart and brain (peripheral vascular dysfunction)

• antidepressants (such as tricyclic antidepressants or neuroleptics), as they may reduce or eliminate the effect of Catapresan and may provoke or worsen disturbances in blood pressure regulation

• medicines that reduce the activity of the central nervous system (such as opioid agonists, analgesics, barbiturates, sedatives, anesthetics), as clonidine may enhance their effects.

Catapresan and alcohol
The effects of alcohol may be enhanced by clonidine; therefore, alcohol consumption during treatment with clonidine is not recommended.
It has been observed that in cases of alcohol excess and high doses of a medicine used to treat mental disorders (called haloperidol) administered intravenously, high doses of clonidine may increase disturbances in heart rhythm (cardiac arrhythmia).
Pregnancy, breast-feeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breast-feeding, ask your doctor or nurse for advice before this medicine is administered to you.
Pregnancy
Available data on the use of clonidine in pregnant women are limited.
During pregnancy, Catapresan, like any other medicine, should only be administered if clearly needed and under direct medical supervision. In such cases, your doctor must carefully monitor both mother and baby.
Clonidine crosses the barrier separating maternal and fetal blood (placental barrier) and may slow the fetal heart rate.
There is inadequate experience regarding the long-term effects of prenatal exposure to the medicine.
During pregnancy, oral clonidine-containing medicines are preferred.
Intravenous administration of clonidine should be avoided.
Animal studies have not shown harmful effects on the fetus.
After delivery, a transient increase in the newborn's blood pressure may occur.
Breast-feeding
Clonidine passes into breast milk.
Due to insufficient data on the effects of clonidine in newborns, the use of Catapresan is not recommended during breast-feeding.
Fertility
No studies have been conducted on effects on fertility in humans. Available studies have not shown harmful effects on fertility.
Driving and using machines
No studies have been conducted to evaluate the effects on the ability to drive vehicles or use machinery.
However, during treatment with Catapresan, the following possible adverse effects may occur: dizziness, physical and mental relaxation (sedation), and difficulty focusing images (accommodation disorders) (see section 4, "Possible side effects").
Therefore, exercise particular caution when driving a vehicle or operating machinery. If you experience any of the above-mentioned adverse effects, you should avoid potentially dangerous activities such as driving or operating machinery.
Your doctor will assess whether you should be accompanied when leaving the hospital.
Catapresan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is practically "sodium-free".

3. How to use Catapresan

Adults aged 18 years and over
This medicine will be administered to you in a hospital setting under close supervision by qualified healthcare professionals.
Treatment of hypertension requires constant medical supervision, and your doctor will determine the dose of
Catapresan based on your individual response.
Catapresan will be administered by qualified medical personnel via subcutaneous injection (under the
skin), intramuscular injection (into a muscle), or slow intravenous injection (into a vein).

If you have reduced kidney function (renal insufficiency)
The dose must be determined by your doctor:

• according to your individual response to the medicine
• according to the degree of kidney function impairment. Your doctor must continuously monitor your kidney function. Dialysis normally removes only small amounts of clonidine from the blood; therefore, no additional doses of clonidine are required after dialysis.

Use in children and adolescents
Use in children and adolescents under 18 years of age is not recommended, as safety and efficacy have not been established.

If you use more Catapresan than you should
Symptoms
If you are given an excessive dose of Catapresan, you may experience: reduced pupil size (pupillary constriction), deep sleep with reduced response to normal stimuli (lethargy), decreased heart rate, i.e. number of heartbeats per minute (bradycardia), low blood pressure (hypotension), low body temperature (hypothermia), drowsiness progressing to coma, breathing difficulties including temporary cessation of breathing (apnea), and unexpected increase in blood pressure (paradoxical hypertension).

Treatment
If you are given an excessive dose of Catapresan, gastric lavage will be performed and appropriate therapy will be administered.

If you stop treatment with Catapresan
This medicine will be administered by specialized medical personnel; therefore, discontinuation will occur only under medical supervision.
However, please note the following:

• sudden discontinuation of Catapresan treatment may cause a rapid increase in blood pressure, manifesting, for example, as restlessness, sensation of rapid heartbeat (palpitations), nervousness, tremor, headache (cephalalgia), nausea, etc. If discontinuation of Catapresan treatment becomes necessary, your doctor will gradually reduce the dose over a period of 2–4 days;
• consult your doctor immediately if you experience a marked increase in blood pressure after stopping Catapresan treatment.

If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most side effects are mild and tend to decrease during the course of treatment.
The following is a list of side effects by frequency:

Very common (may affect more than 1 in 10 people)

• dizziness (vertigo)
• physical and mental relaxation (sedation). Sedation may occur during the first week of treatment and usually diminishes with continued therapy. If necessary, consult your doctor, who may reduce the dose
• drop in blood pressure upon standing, accompanied by symptoms such as dizziness/light-headedness (orthostatic hypotension)
• dry mouth

Common (may affect up to 1 in 10 people)

• depression
• sleep disturbances
• headache (cephalalgia)
• constipation
• pain in the glands located in the mouth, face, and neck (salivary glands)
• nausea
• vomiting
• in men, difficulty achieving or maintaining an erection suitable for sexual intercourse (erectile dysfunction)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• abnormal interpretation of reality (delusional perception)
• perception of things that do not exist in reality (hallucinations)
• nightmares
• sensation of numbness and tingling in the legs, arms, or other body parts (paraesthesia)
• slow and irregular heartbeat (sinus bradycardia)
• circulatory disorder (Raynaud's syndrome)
• skin redness accompanied by itching (urticaria)
• itching
• skin rashes (rash)
• malaise

Rare (may affect up to 1 in 1,000 people)

• reduced tear production
• heart difficulty in pumping blood throughout the body due to disruption of the heart's electrical conduction system (atrioventricular block)
• dry nose
• intestinal disorder characterized by slowed intestinal transit and reduced ability to propel food through the intestine (pseudo-obstruction of the large intestine)
• hair loss (alopecia)
• breast enlargement (gynaecomastia)
• increased blood sugar (hyperglycaemia)

Frequency not known (cannot be estimated from the available data)

• confusion
• reduced sexual desire (reduced libido)
• difficulty focusing images (accommodation disorders)
• slow and irregular heartbeat (bradyarrhythmia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or nurse.
You can also report side effects directly via the national reporting system for adverse reactions. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Catapresan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Catapresan contains

• The active substance is: clonidine hydrochloride (one vial contains 150 micrograms of clonidine hydrochloride)
• The other components are: sodium chloride (see section “Catapresan contains sodium”), hydrochloric acid, water for injections.

Description of the appearance of Catapresan and contents of the pack
Injectable solution. Each pack contains 5 vials of colourless glass with 1 ml each.
Marketing Authorization Holder
Glenwood GmbH
Pharmazeutische Erzeugnisse
Arabellastr. 17
81925 Munich
Germany
[email protected]
Manufacturer
Boehringer Ingelheim España S.A.
San Cugat del Vallès – Barcelona (Spain)

The following information is intended exclusively for physicians or healthcare professionals
Subcutaneous or intramuscular administration of Catapresan 150 micrograms/ml injectable solution should be performed with the patient lying in a supine position to avoid possible orthostatic phenomena.
The injection may be administered subcutaneously, intramuscularly, or by slow intravenous injection (one vial diluted in at least 10 ml of physiological saline solution, injection duration 10 minutes). For intravenous infusion, a dose of 0.2 micrograms/kg/min is recommended. The infusion rate should not exceed 0.5 micrograms/kg/min to avoid transient increases in blood pressure. The dose administered by infusion should not exceed 150 micrograms.
If necessary, vials may be administered parenterally up to 4 times daily.
This medicinal product must not be mixed with other products except physiological saline solution.