Betapam 5 mg Tablets

Diazepam belongs to a group of medicines called benzodiazepines. Diazepam helps in the treatment of anxiety and muscle spasm (cramps). BETAPAM is a long-acting medicine used for:

• Anxiety
• Muscle spasm (cramps) such as those caused by cerebral spasticity

Do not take BETAPAM:

• if you are hypersensitive (allergic) to diazepam or any of the other ingredients of BETAPAM (listed in section 6),
• if you have breathing or lung problems,
• if you have severe liver problems,
• if you have a condition called “sleep apnoea syndrome” (where your breathing stops when you are asleep),
• if you have a condition called “myasthenia gravis” (where your muscles are weak and get tired easily),
• if you are addicted to CNS depressants (e.g., tranquilisers, sleep medicine) including alcohol,
• if you have problems with phobias (strong fears) or obsessions (troublesome, unwanted and repeated thoughts, ideas or feelings).
• Do not use BETAPAM alone to treat depression or anxiety associated with depression.
• if you have an allergy to BETAPAM or any other benzodiazepine medicine (e.g. clonazepam, flurazepam and temazepam)

Warnings and precautions

Take special care with BETAPAM:

• if you regularly drink alcohol and/or CNS depressants, or take recreational drugs.
• if you have had problems with alcohol or drug abuse in the past.
• if you experience total or partial memory loss, memory loss is more likely to occur when taking high doses of BETAPAM.
• if you have acute narrow-angle glaucoma (eye disorder where the nerve connecting the eye to the brain is damaged, usually due to high eye pressure).
• if you have liver, kidney, lung or heart problems.
• if you have difficulty in swallowing or breathing or suffer from a lung disease called chronic obstructive pulmonary disease.
• if you are being treated for depression.
• if you have suicidal thoughts.
• if you have a personality disorder.
• if you are elderly or weak, your doctor will decide whether to prescribe a lower dose of BETAPAM for you.
• if you suffer from arteriosclerosis (build-up of fats, cholesterol and other substances in and on the artery walls).
• if you have low blood pressure.
• if you are suffering from porphyria.
• if you are driving a car and/or operating machinery.
• if you have been told that you cannot tolerate or digest some sugars.
• if you are to give BETAPAM to a child younger than 6 months of age. BETAPAM is not recommended for use in this age group unless there are no other treatment options.

Symptoms such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other side effects are known to occur when using BETAPAM. Should this occur, the use of BETAPAM should be discontinued. They are more likely to occur in the elderly.

Patients taking BETAPAM have developed blood disorders and periodic blood counts are recommended.

Do not share medicines prescribed for you with any other person. Always take BETAPAM exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure. You should be treated for as short as possible. Treatment should not be longer than 2 - 3 months, including the time that you are coming off your tablets. You should consult your healthcare professional regularly to see if you need to continue your treatment, especially if you are symptom free.

• You will be started with a low dose of BETAPAM. Your doctor will slowly increase it until you are taking the right dose for you. Your doctor will always give the lowest possible dose that works for you.
• Your doctor will want you to take BETAPAM for the shortest possible time.
• The usual adult dose is 5 - 10 mg initially. Depending on the severity of your symptoms, your doctor may prescribe a dose of 5 - 20 mg daily.
• If you are elderly or very ill, or weak, or have problems with your liver or kidneys, your doctor may give you a lower dose.
• Children’s dose: Your doctor will prescribe the correct dose for your child, according to your child’s weight and severity of his/her illness.
• Your doctor will tell you how long your treatment with BETAPAM will last.
• If you have the impression that the effect of BETAPAM is too strong or too weak, tell your doctor or pharmacist.

If you take more BETAPAM than you should

If you take more BETAPAM than you should, or if someone else takes your BETAPAM tablets by mistake, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. If you take too many tablets you may feel sleepy, have difficulty controlling your movements (lack of coordination), or have slow or slurred speech or jerky eye movements.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take BETAPAM

• If you forget to take a dose, miss the skipped dose. Then take the next dose when it is due.
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking BETAPAM

• Do not stop taking BETAPAM without talking to your doctor.
• When you stop taking BETAPAM, your anxiety may return and you may experience sleeping problems, and you may get withdrawal symptoms, especially if you stop too quickly. For the symptoms you may have, see “Withdrawal symptoms” under “Possible side effects”.
• When it is time to lower your dose or stop taking BETAPAM, it must be done slowly. This lowers the chance of you having withdrawal symptoms. Your doctor will tell you how to do this.

BETAPAM can have side effects. Not all side effects reported for BETAPAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BETAPAM, please consult your health care provider for advice.

If any of the following happens, stop taking BETAPAM and tell doctor immediately or go to the casualty department at your nearest hospital:

• Chest pain which may spread to your neck and shoulders and down your left arm. This may be a sign of a heart attack.
• Breathing problems (respiratory depression). Early signs include sudden noisy, difficult and uneven breathing. Your skin may become blue.
• A feeling of fullness in your bladder and urge to pass water, but then difficulty emptying your bladder.
• Being restless, aggressive, angry, irritable or agitated.
• Nightmares and seeing or hearing things that are not really there (hallucinations).
• Mental problems such as delusions (believing in things that are not real) or losing contact with reality.
• A change in your behaviour that is out of character.
• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• Rash or itching,
• Fainting.

These are very serious side effects. If you have them, you may have had a serious reaction to BETAPAM. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Feeling tired
• Weak muscles

Less frequent side effects:

• Poor coordination, including feeling unsteady when you walk
• Slow or slurring of speech
• Headache
• Feeling dizzy
• Uncontrollable movements, for example of your hands (tremor)
• Anterograde amnesia (difficulty remembering new things)
• Confusion
• Depression
• Being less alert
• Blood disorders (you may develop sore throats, nose bleeds or infections)
• Sleepiness, feeling disorientated

• Low blood pressure. The signs include feeling dizzy or light-headed
• Uneven heartbeat, heart failure and cessation of heartbeat (cardiac arrest)
• Respiratory arrest (cessation of breathing)

• Feeling sick (nausea)
• Constipation
• Diarrhoea
• Dry mouth
• Indigestion
• Increased salivation

• Changes in sexual drive (libido)
• Irregular menstruation

• Problems with your eyesight, including double or blurred vision.

• Skin rashes
• Jaundice (yellowing of your skin or the white of your eyes).

• Changes in how well your liver is working (shown by blood tests).
• Loss of bladder control (wetting yourself).

When you take BETAPAM you are at risk of falling and breaking your bones. This risk is increased if you are elderly or are taking other sedatives (including alcohol).

You can become dependent on benzodiazepine medicines like BETAPAM. This means that if you stop treatment suddenly, or lower the dose too quickly, you may get withdrawal symptoms. The symptoms can include:

• Headache
• Muscle pain and feeling restless
• Feeling very worried, tense, confused or bad tempered.
• Emotional withdrawal
• Memory loss

• Feeling sensitive to light, noise and touch
• Seeing or hearing things that are not really there (hallucinations)
• Tingling and numb in your arms and legs
• Feeling lost or losing contact with reality
• Fits (seizures)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who umc.org) found on SAHPRA website. Suspected adverse reactions can also be reported directly to the HCR via email: [email protected] or tel: +27(0) 12 643 2000. By reporting side effects, you can help provide more information on the safety of BETAPAM.

Store all medicines out of reach of children. Store at or below 25 °C in a cool, dry place. Protect from light and moisture. Store in the original package. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).