Description

---

NOFORGE HCT contains 3 prescription medicines:
1. amlodipine, a calcium channel blocker
2. valsartan, an angiotensin receptor blocker,
3. hydrochlorothiazide, a diuretic (water pill)
NOFORGE HCT may be used to lower blood pressure in adults when 2 medicines to lower your high blood pressure are not enough.
NOFORGE HCT has not been studied in children under 18 years of age.

---

BEFORE YOU TAKE NOFORGE HCT

Do not take NOFORGE HCT
if you have low or no urine output (anuria).

Tell your doctor about all of your medical conditions, including if you:
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. NOFORGE HCT may pass into your milk. Do not breastfeed while you are taking NOFORGE HCT.
• are allergic to any of the ingredients in NOFORGE HCT.
• have heart problems
• have liver problems
• have kidney problems
• are vomiting or having a lot of diarrhea
• have or had gallstones
• have Lupus
• have low levels of potassium (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm) or magnesium in your blood
• have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, and twitching).
• have high levels of uric acid in the blood.
• have ever had a reaction called angioedema, to another blood pressure medicine. Angioedema causes swelling of the face, lips, tongue, and may cause difficulty breathing.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and NOFORGE HCT could affect each other, causing serious side effects.
Especially tell your doctor if you take:
• simvastatin or other cholesterol-lowering medicine
• other medicines for high blood pressure or a heart problem
• water pills (“diuretics”)
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically.
• salt substitute containing potassium. Your doctor may check the amount of potassium in your blood periodically.
• diabetes medicine including insulin
• narcotic pain medicines
• sleeping pills and antiseizure medicines called barbiturates
• lithium, a medicine used to treat some types of depression
• aspirin or other medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen or naproxen
• steroids
• alcohol
• digoxin or other digitalis glycosides (a heart medicine)
• muscle relaxants (medicines used during operations)
• certain cancer medicines, like cyclophosphamide or methotrexate
• medicines used to prevent and treat fungal infections (such as ketoconazole, itraconazole)
• medicines used to treat bacterial infections (such as clarithromycin, telithromycin)
• certain antibiotics (rifamycin group), a drug used to protect against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of valsartan.

Know the medicines you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine.

---

HOW TO TAKE NOFORGE HCT

• Take NOFORGE HCT exactly as your doctor tells you.
• Take NOFORGE HCT one time each day.
• NOFORGE HCT can be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at the regular time.
• If you take too much NOFORGE HCT, call your doctor or Poison Control Center, or go to the emergency room.
• Tell all your doctors and dentist you are taking NOFORGE HCT. This is especially important if you:
are going to have surgery OR go for kidney dialysis

---

POSSIBLE SIDE EFFECTS

NOFORGE HCT may cause serious side effects including:
• harm to an unborn baby causing injury or death.
• low blood pressure (hypotension). Low blood pressure is most likely to happen if you:
• take water pills
• are on a low salt diet
• have heart problems
• get dialysis treatments
• get sick with vomiting or diarrhea
• drink alcohol.
Lie down if you feel faint or dizzy. If you faint (lose consciousness), stop taking NOFORGE HCT. Call your doctor right away.
• Get emergency help if you get worse chest pain or chest pain that does not go away.
• kidney problems. Kidney problems may become worse in people that already have kidney disease.
Some people will have changes in blood tests for kidney function and may need a lower dose of NOFORGE HCT. Call your doctor if you have swelling in your feet, ankles, or hands, or unexplained weight gain. If you have heart failure, your doctor should check your kidney function before prescribing NOFORGE HCT.
• laboratory blood test changes in people with heart failure. Some people with heart failure who take valsartan, one of the medicines in NOFORGE HCT, have changes in blood tests including increased potassium and decreased kidney function.
• allergic reactions
• skin rash. Call your doctor right away if you get an unusual skin rash.
• eye problems. One of the medicines in NOFORGE HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting NOFORGE HCT. Tell your doctor right away if you have:
• decrease in vision
• eye pain
The most common side effects of NOFORGE HCT include:
• dizziness
• swelling (edema) of the hands, ankles, or feet
• headache
• indigestion
• tiredness
• muscle spasms
• back pain
• nausea

Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of NOFORGE HCT. For more information, ask your doctor or pharmacist.

---

HOW TO STORE NOFORGE HCT

• Keep out of the reach and sight of children.
• Do not use NOFORGE HCT after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
• Do not store above 30oC.
• Store this blister in the original package or keep the bottle tightly closed in order to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

---

FURTHER INFORMATION

Active ingredients: amlodipine besylate, valsartan, and hydrochlorothiazide
The inactive ingredients of all strengths of the tablets are crospovidone, magnesium stearate, microcrystalline cellulose, and colloidal anhydrous silica. The film coating contains hypromellose, talc, macrogol 4000, and may contain titanium dioxide or yellow and red iron oxides.
Packed in blisters