Diconal 10 mg + 30 mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Diconal 10 mg + 30 mg Tablets. It will be referred to as Diconal Tablets for ease hereafter.

1. What Diconal Tablets are and what they are used for
2. What you need to know before you take Diconal Tablets
3. How to take Diconal Tablets
4. Possible side effects
5. How to store Diconal Tablets
6. Contents of the pack and other information

This medicine contains dipipanone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

• if you are allergic to dipipanone hydrochloride, cyclizine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have allergic reactions which include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing
• if you have any lung disease (such as bronchitis), difficulty in breathing, or have excessive phlegm
• if you suffer from any obstructive airway disease
• if you are having an asthma attack
• if you suffer from heart failure as a result of chronic lung disease
• if you are addicted to, or often drink large amounts of alcohol
• if you have recently suffered any head injury or have been told that you have raised pressure around your brain
• if you are taking, or have recently taken (within the last 14 days) a medicine from a group of anti depressants called monoamine oxidase inhibitors (MAOIs)
• if you have a bowel disorder such as ulcerative colitis
• if you are at risk of paralytic ileus (a condition where there is inactivity or paralysis within the bowel which stops the passage of material within the intestine)
• if you suffer from abdominal pain/ spasm (spasms of the biliary tract and/or renal tract). Do not take Diconal Tablets immediately after having abdominal surgery (biliary tract surgery)
• if you are about to undergo surgery or have had surgery within the past 24 hours
• if you have severe liver or kidney problems.

Talk to your doctor, pharmacist or nurse before taking Diconal Tablets if you:

• are in a weakened or debilitated state
• suffer from involuntary muscle movement (convulsive disorders)
• have any problems with your thyroid, adrenal or pituitary glands
• are a man with an enlarged prostate gland
• are suffering from shock
• have diabetes
• suffer from an immune disorder characterised by muscle weakness (myasthenia gravis)
• have low blood pressure due to loss of blood or fluids
• suffer from pancreatitis (which can cause severe pain in the abdomen or back)
• suffer from an obstructive disease affecting the stomach and intestines
• suffer from an inflammatory bowel disorder
• have a disease affecting the series of passageways that carry bile into the intestines
• have difficulty breathing (impaired respiratory function)
• have difficulty passing urine (urinary retention)
• have severe heart failure
• have been told you have a rare condition called porphyria (a blood disease)
• suffer from an eye disease caused by a rise of pressure within the eye (glaucoma)
• have a tumour of the adrenal gland (phaeochromocytoma).

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Diconal tablets to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else.

Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

If any of these apply to you, or if you are not sure, tell your doctor before taking Diconal Tablets.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

This is especially important if you are taking:

• medicines for problems such as depression, anxiety or psychosis, or are taking a sedative (usually to treat insomnia)
• gabapentin (to treat epilepsy or nerve pain)
• medicines used to relieve high blood pressure
• muscle relaxants
• pethidine (used in the treatment of pain)
• mexiletine (used in the treatment of heart rhythm disorders)
• metoclopramide (used in the treatment of nausea and vomiting)
• monoamine oxidase inhibitors (see section ‘Do not take…’)
• cimetidine (used in the treatment of heartburn and ulcers)
• any medicines which belong to a group of medicines called anticholinergic medicines. This may be for Parkinson’s disease, asthma etc. Check with your doctor if you are not sure
• aminoglycoside antibiotics, such as gentamicin (used in the treatment of infections)
• a medicine called dexamphetamine (used to treat narcolepsy or attention deficit disorder)
• diuretics (used to promote urine production)
• hydroxyzine (used to relieve anxiety caused by some mental disorders)
• propranolol (used in the treatment of high blood pressure or anxiety)
• St John’s Wort (a herbal medication used in the treatment of depression)
• ritonavir (used in the treatment of HIV and AIDS).

Diconal Tablets may also interfere with some laboratory tests performed by your doctor.

Do not drink alcohol while taking Diconal Tablets, as the tablets can increase the effects of alcohol.

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

Pregnancy

Do not take Diconal tablets if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Diconal tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breastfeeding

Do not take Diconal tablets while you are breastfeeding as dipipanone passes into breast milk and will affect your baby.

Diconal Tablets may make you feel dizzy or drowsy. If they affect you in this way, do not drive or operate any machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• do not drive 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:
  • the medicine 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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Diconal Tablets are rarely used in children. No guidelines can be given on the recommended dose for children.

Diconal Tablets may cause confusion in this age group. Careful monitoring is advised.

Symptoms of overdose include difficulty breathing, slower or faster heartbeat, pin point pupils, low blood pressure, drowsiness, dry mouth, nose and throat, blurred vision, difficulty passing urine, dizziness, lack of balance and coordination, weakness, excitability, disorientation, impaired judgment, hallucinations, muscle spasms, involuntary movements, fits, and high temperature. If you take more Diconal Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose to make up for a forgotten dose

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as yawning, dilated pupils, tears, a runny nose, sneezing, muscle tremors, weakness, anxiety, irritability, agitation, feeling your heartbeat (palpitations), increased blood pressure, difficulty sleeping, shaking, restlessness, decreased appetite, weight loss, feeling or being sick, diarrhoea, dehydration, an increase in white blood cells, bone pain, stomach pain and cramps, "goose pimples", increased heart rate, breathing rate and temperature, shivering or sweating may occur if you suddenly stop taking this medicine.

• itching or skin rashes
• swelling of the face, lips or throat
• difficulty in breathing or wheeziness.

tell your doctor immediately. These may be signs of an allergic reaction.

• feeling very tired, experience unexpected bruising or bleeding, or more infections (e.g. colds and sore throats) than usual please tell your doctor as soon as possible, your doctor may decide to conduct tests on your blood periodically as a result of these symptoms
• inflammation of the pancreas which causes severe pain in the abdomen and back
• decreased consciousness
• experiencing a loss of contact with reality
• fits
• loss of coordination or unusual body movements, particularly of the hands, arms or legs
• fatigue, nausea, loss of appetite, or yellow skin or eyes could be due to inflammation of the liver (hepatitis)
• abdominal pain/spasm could be due to condition known as biliary pain/spasm.

The following side effects are reported with:

Uncommon (may affect up to 1 in 100 people)

Drug Withdrawal

When you stop taking Diconal tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

Not known frequency (frequency cannot be estimated from the available data):

• a dry mouth, nose or throat
• sweating
• feeling of weakness
• generally feeling unwell
• feeling cold
• headaches
• facial flushing
• dizziness, light-headedness or vertigo
• low blood pressure/fainting, coma
• high blood pressure
• increased blood pressure within the head
• swelling of the ankles, feet or fingers
• increase in heart rate
• slow or irregular heart beat
• palpitations
• nervousness or restlessness, agitation, confusion and mood changes
• uncomfortable mood or feeling of happiness
• seeing or hearing things that are not really there (hallucinations)
• ringing in the ears
• breathing difficulties such as wheezing
• a decreased cough reflex
• itching or nettle rash
• sensitivity to light
• abdominal pain
• constriction of the pupils (small pupils)
• blurred vision
• involuntary rolling of the eyes
• visual disturbances
• feeling sick and being sick
• constipation
• acid reflux
• diarrhoea
• loss of appetite
• indigestion
• taste disturbances
• difficulty or pain in passing water
• difficulty in sleeping
• tiredness or drowsiness
• muscle twitches, spasms or tremors
• a tingling/burning sensation of the skin
• jaundice (yellowing of the skin and whites of the eyes)
• blood tests which show changes in the way the liver is working
• difficulty in speaking
• changes in blood counts which may:
  • make infections more likely, or
  • make the skin pale and cause weakness or breathlessness, or
  • increase the risk of bleeding or bruising
• decreased sex drive
• erectile dysfunction (in men)
• absence of menstrual periods (in women).
• dependence and addiction (see section “How do I know if I am addicted?”).
• unpleasant sensation or an overwhelming urge to move the legs (also called Restless Legs Syndrome)

Some people may become tolerant of, or addicted to, this medicine when treatment continues for a long time.

If you notice any of the following signs whilst taking Diconal tablets, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substances are dipipanone hydrochloride 10 mg and cyclizine hydrochloride 30 mg.

The other ingredients are lactose, starches, erythrosine (E127), gelatin and magnesium stearate.

Diconal Tablets are deep pink in colour, scored, coded F3A and are supplied in blister packs containing 50 tablets.