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TENSIUM, DIAZEPAM 5 MG - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - TENSIUM, DIAZEPAM 5 MG

DIAZEPAM TABLETS

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.

KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF DIAZEPAM.

IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.

What is in Diazepam tablets?

The active ingredient of this medicine is Diazepam BP.

Diazepam tablets come in three strengths:

Diazepam 2 mg tablets which contains 2mg Diazepam, together with the ingredients Lactose, Maize starch, Pregelatinised maize starch and Magnesium stearate (E572).

Diazepam 5 mg tablets which contains 5mg Diazepam, together with the ingredients Lactose, Maize starch, Pregelatinised maize starch, Magnesium stearate (E572) and Quinoline yellow (E104).

Diazepam 10 mg tablets which contains 10mg Diazepam, together with the ingredients Lactose, Maize starch, Magnesium stearate (E572) and Indigo carmine DFC blue 2 (E132).

Diazepam 2mg is a round, flat, white tablet with bevelled edges and embossed 2mg/DDSA.

Diazepam 5mg is a round, flat, pale yellow tablet with bevelled edges and embossed 5mg/DDSA.

Diazepam 10mg is a round flat, pale blue tablet with bevelled edges and a scoreline, and is embossed Tensium.

All three strengths are available in containers of 50, 100, 500 and 1,000 tablets.

Diazepam belongs to a group of medicines, the benzodiazepines that slow down the nervous system and are known as Central Nervous System (CNS) depressants.

The name and address of the Product Licence holder of Diazepam is:

Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P. C. 1060, Cyprus

The name and address of the manufacturer of Diazepam is: Meridian Healthcare (UK) Ltd., 208–214 York Road, Battersea, London SW11 3SD

Why have you been prescribed Diazepam?

In adults Diazepam is used for the short-term relief (2 – 4 weeks only) of nervousness or tension which is disabling or which can cause unacceptable distress either on its own or together with trouble in falling asleep or in sleeping, known as insomnia.

Diazepam is also used to help relax muscles or relieve muscle spasm which may occur with conditions such as fibrositis and arthritis, bursitis and cervical spondylosis, and to treat certain types of seizure such as those of epilepsy and tetanus.

Diazepam is used for the treatment of the symptoms of alcohol withdrawal.

Diazepam is also used for premedication for dental and surgical procedures.

In children Diazepam is used for the treatment of sleepwalking (somnambulism) and nightmares (night terrors). It is also used in certain conditions to help relax muscles and relieve muscle spasm.

Diazepam is also used for premedication for dental and surgical procedures.

BEFORE TAKING THIS MEDICINE

Before taking this medicine tell your doctor if you have ever had any unusual or allergic reactions to diazepam or other benzodiazepines. Also tell your doctor or pharmacist if you are allergic to any other substances, such as foods, preservatives or dyes.

The presence of other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor if you have any other medical problems, especially:

  • Any condition that affects your breathing, such as asthma, emphysema.
  • Any liver or kidney problems for which you have or are receiving treatment.
  • Raised eyeball pressure (Glaucoma)
  • Depression

The effect of taking Diazepam with other medicines

This medicine will add to the effects of alcohol and other medicines that slow down the Central Nervous System (CNS), possibly causing drowsiness. Some examples of CNS depressants are antihistamines (medicines for hayfever and other allergies); sedatives; tranquillisers, sleeping medicines; pain relieving medicines; barbiturates; medicines for seizures; muscle relaxants; anaesthetics including some dental anaesthetics.

Make sure you doctor is informed of any medication you are taking, whether it has been prescribed or bought without a prescription. It is particularly important that your doctor is aware of any medicines you are taking which have been mentioned in the paragraph above.

If you go to a doctor, dentist or hospital for any reason, tell them you are taking Diazepam.

PRECAUTIONS WHILE USING THIS MEDICINE

Driving and using machines


When Diazepam has been combined during treatment with CNS depressants, sedative effects of these are likely to be intensified, and may last for a few days after you have stopped taking this medicine.

Diazepam can affect your ability to drive and use machines as it may make you feel sleepy and dizzy.

Do not drive or operate dangerous machinery while taking this medicine until you know how it affects you.

  • It is an offence to drive if this medicine affects your ability to drive.
  • However, you would not be committing an offence if:

  • – Diazepam has been prescribed to treat a medical or dental problem and;

  • – you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and;

  • – it was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is TENSIUM and how does it work?

TENSIUM is a medication that contains Diazepam 5 mg, which is used to relieve anxiety, muscle spasms, and seizures. It works by calming the brain and nerves, helping to promote relaxation.

Who can take TENSIUM?

TENSIUM is generally prescribed for adults and may be used in children for certain conditions. Always consult your healthcare provider to determine if it's suitable for you.

What should I do if I miss a dose of TENSIUM?

If you miss a dose of TENSIUM, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and return to your regular schedule.

Can I drink alcohol while taking TENSIUM?

It is advised to avoid alcohol while taking TENSIUM, as it can increase drowsiness and other side effects.

What are the common side effects of TENSIUM?

Common side effects may include drowsiness, dizziness, tiredness, blurred vision, or unsteadiness. If these persist or worsen, contact your healthcare provider.

How long does it take for TENSIUM to work?

TENSIUM typically starts to work within 30 minutes to an hour after taking it, but individual responses may vary.

Can I use TENSIUM for sleep problems?

While TENSIUM can help with anxiety that may interfere with sleep, it's important to consult with your doctor before using it specifically for sleep issues.

Are there any drug interactions I should be aware of with TENSIUM?

Yes, TENSIUM can interact with other medications such as opioids, antidepressants, or muscle relaxants. Always inform your doctor about all the medications you are taking.

Is it safe to stop taking TENSIUM suddenly?

No, stopping TENSIUM suddenly can lead to withdrawal symptoms. Your doctor will recommend a gradual dose reduction if discontinuation is necessary.

Can pregnant or breastfeeding women take TENSIUM?

TENSIUM should only be used during pregnancy or breastfeeding if clearly needed. Discuss the risks with your healthcare provider.

What should I do if I experience severe side effects from TENSIUM?

If you experience severe side effects like difficulty breathing, swelling of the face or throat, or severe confusion, seek emergency medical attention immediately.

Can older adults take TENSIUM safely?

Older adults may be more sensitive to the effects of TENSIUM. Your doctor will provide a careful evaluation to determine appropriate dosing.

Does TENSIUM affect my ability to drive?

Yes, since TENSIUM can cause drowsiness and impair coordination, it's advised not to drive or operate heavy machinery until you know how it affects you.

Is there a risk of addiction with TENSIUM?

Yes, there is a potential risk of dependence and addiction with prolonged use of Diazepam. Your doctor will monitor your treatment closely.

How should I store TENSIUM?

Store TENSIUM at room temperature away from moisture and heat. Keep it out of reach of children.

Is TENSIUM suitable for treating panic attacks?

TENSIUM may help relieve symptoms associated with anxiety and panic attacks; however, consult your healthcare provider for an appropriate treatment plan.

What lifestyle changes can support my treatment with TENSIUM?

Incorporating stress-reducing activities like yoga or meditation and maintaining a healthy diet can support your treatment plan alongside taking TENSIUM.

How long can I safely take TENSIUM?

The duration of treatment with TENSIUM will depend on the individual case. Follow your doctor's recommendations regarding the length of use.

Where can I find more information about managing my condition while on TENSIUM?

You can ask your healthcare provider or pharmacist for more information about managing your condition and any resources they recommend.