Compounded Tadalafil Chewable Tablet
1. What are Tadalafil Chewable Tablets and what are they used for
Tadalafil Chewable Tablets contain the active substance tadalafil, which belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors. They are used for the treatment of erectile dysfunction in adult men, a common condition which implies difficulties in getting or keeping an erection. There may be physical or psychological causes for ED, or a mixture of both. If a medical provider determines it to be safe and appropriate, PDE5 inhibitors can also be used to treat premature ejaculation and to improve overall sexual quality of life. They can also help you get another erection more easily after orgasm.
Tadalafil Chewable Tablets will only work when you are sexually stimulated. They reduce the action of the natural chemical in your body that makes erections go away. Tadalafil Chewable Tablets allow an erection to last long enough for you to satisfactorily complete sexual activity.
This is a compounded prescription product and has not been approved by the MHRA.
2. What you need to know before you take Tadalafil Chewable Tablets
Do not take Tadalafil Chewable Tablets
If you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
If you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your clinician.
If you have serious heart disease or recently had a heart attack within the last 90 days.
If you have recently had a stroke within the last 6 months.
If you have low blood pressure or uncontrolled high blood pressure.
If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
If you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Tadalafil Chewable Tablets have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, tell your pharmacist or medical provider.
Warnings and precautions
Talk to your pharmacist or medical provider before taking Tadalafil Chewable Tablets.
Take special care with Tadalafil Chewable Tablets
If you have heart trouble. It may be risky for you to have sex.
If you suffer from an irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
If you have a physical condition affecting the shape of the penis. This includes conditions called angulation, Peyronie’s disease and cavernosal fibrosis.
If you have an illness that can cause erections which won’t go away (priapism). These include sickle cell disease, multiple myeloma and leukaemia.
If you have stomach ulcers (also called gastric or peptic ulcers).
If you have a bleeding disorder (such as haemophilia).
If you have serious liver or kidney problems.
If you are using any other treatments for erection difficulties, (see section Other medicines and Tadalafil Chewable Tablets).
If you experience sudden decrease or loss of vision or loss of hearing, stop taking Tadalafil Chewable Tablets and contact your doctor immediately.
It is not known if tadalafil is effective in patients who have had pelvic surgery or removal of all or part of the prostate gland in which nerves of the prostate are cut.
Children and adolescents
Tadalafil Chewable Tablets are not intended for use by children or adolescents under 18.
Other medicines and Tadalafil Chewable Tablets
Do not use Tadalafil Chewable Tablets combined with any other treatment for erectile dysfunction.
Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Some medicines may cause problems, especially these:
Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with Tadalafil Chewable Tablets could seriously affect your blood pressure.
Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
Ritonavir or indinavir, medicines for HIV.
Ketoconazole or itraconazole, antifungal medicines
Erythromycin or clarithromycin, macrolide antibiotics
Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
Tadalafil Chewable Tablets with food, drink and alcohol
You can take Tadalafil Chewable Tablets with or without food but preferably not after a heavy or high-fat meal as this may delay the effect.
Don’t drink grapefruit juice when you use Tadalafil Chewable Tablets. It can interfere with the usual effect of the medicine.
Alcoholic drinks can make erection difficulties worse.
Pregnancy and breast-feeding
Tadalafil Chewable Tablets are not for use by women.
Driving and using machines
Tadalafil Chewable Tablets might make some people feel dizzy or affect their vision. If you feel dizzy, or if your vision is affected after taking Tadalafil Chewable Tablets don’t drive or operate any tools or machines.
3. How to take Tadalafil Chewable Tablets
Always take as directed by your healthcare provider. Check with your healthcare provider if you are not sure.
If prescribed for as-needed use:
Chew and swallow one tablet 30 - 120 minutes prior to sexual activity as needed.• Do not take more than 1 dose (1 tablet) within a 24 hour time period.
If prescribed for daily use:
Chew and swallow one tablet once daily without regard to sexual activity.
Do not take more than 1 dose (1 tablet) within a 24 hour time period.
Do not take Tadalafil Chewable Tablets with any other forms of Tadalafil or Cialis®.
Do not take Tadalafil Chewable Tablets more than once a day.
Tell your pharmacist or medical provider if you think Tadalafil Chewable Tablets are too strong or too weak. They may suggest a switch to an alternative Tadalafil Chewable Tablets formulation with a different dose, depending on how well it works for you.
If you take more Tadalafil Chewable Tablets than you should
Men who take too much Tadalafil Chewable Tablets may experience more side effects or may get severe back pain. If you take more Tadalafil Chewable Tablets than you should, tell your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
If you experience any of the following side effects stop using the medicine and seek medical help immediately:
Allergic reactions including rashes (frequency uncommon); chest pain (frequency uncommon); priapism, a prolonged and possibly painful erection which lasts continuously for more than 4 hours after taking Tadalafil (frequency rare); sudden loss of vision (frequency rare).
The chance of having a side effect is described by the following categories:
Common (may affect up to 1 in 10 people): headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.
Uncommon (may affect up to 1 in 100 people): dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (may affect up to 1 in 1,000 people): fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Heart attack and stroke have also been reported rarely in men taking Tadalafil. Most of these men had known heart problems before taking this medicine. Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. Some additional rare side effects have been reported in men taking Tadalafil that were not seen in clinical trials. These include: migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death. The side effect of dizziness has been reported more frequently in men over 75 years of age taking Tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking Tadalafil.
Reporting of side effects
If you get any side effects, talk to your pharmacist or medical provider. This includes any possible side effects not listed in this leaflet. You may also report side effects directly via the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard .
5. How to store Tadalafil Chewable Tablets
Keep this medicine out of the sight and reach of children. Store the tablets at room temperature (between 18 and 25 degrees C) in the packaging provided by the pharmacy. The effectiveness of your medicine may be affected by exposure to extremes of heat, cold, or humidity. Do not use this medicine after the expiry date which is stated on the prescription label. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Tadalafil Chewable Tablets contain
The active substance is tadalafil. Each tablet contains either 6 mg, 8.5 mg, 12 mg or 18 mg of tadalafil. The other ingredients of the tablets are: Magnesium Stearate, Dextrose, Citric Acid, Sucralose, Microcrystalline cellulose, bitterness masking powder, flavouring.
What Tadalafil Chewable Tablets look like and contents of the pack
Tadalafil Chewable Tablets are white with coloured flecks. The tablets are provided in packs with varying numbers of tablets, depending on the prescription.
If you have any questions, talk to your pharmacist or medical provider.
This medicine was compounded and dispensed by London Specialist Pharmacy Limited, Yew Tree Avenue, Dagenham, RM10 7FN, United Kingdom.